|
Device |
filler, bone void, calcium compound |
Product Code | MQV |
Regulation Number |
888.3045
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACRO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AG DIGITAL TECHNOLOGY CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AGNOVOS HEALTHCARE USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALLOSOURCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMEND SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANIKA THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANIKA THERAPEUTICS. INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTOSS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ATPAC MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BACTERIN INTERNATIONAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BAXTER HEALTHCARE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAXTER HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERKELEY ADVANCED BIOMATERIALS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERKELEY ADVANCED BIOMATERIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIO2 TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO2 TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCOMPOSITES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOCOMPOSITES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGENNIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOGENNIX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIOGENNIX, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMET SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSTONE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSTRUCTURES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSTRUCTURES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIOVENTUS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOVENTUS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BONALIVE BIOMATERIALS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONALIVE BIOMATERIALS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BONE SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BONESUPPORT AB |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CELLUMED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLLAGEN MATRIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CONVERG ENGINEERING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORLIBER (SHENZHEN) MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURASAN AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CYTOPHIL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIMENSIONAL BIOCERAMICS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIMENSIONAL BIOCERAMICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIMENSIONAL BIOCERAMICS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DSM BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELUTE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ETEX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ETEX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEISTLICH PHARMA AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAFTYS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HAIDER BIOLOGICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANS BIOMED CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HANS BIOMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOYA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INION OY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTEGRA LIFESCIENCE CORPORTATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRA LIFESCIENCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTRA-LOCK INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ISTO TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KASIOS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KENSEY NASH CORORATION |
|
SE - WITH LIMITATIONS
|
1
|
KENSEY NASH CORPORATION DBA DSM BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KUROS BIOSCIENCES B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
KUROS BIOSCIENCES BV |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LINACOL MUH DAN KIM CEV TEK MED ITH IHR SAN VE TIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SOFAMOR DANEK USA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC SOFAMOR DANEK USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC SOFAMOR DANEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MOLECULAR MATRIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
NANOTHERAPEUTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOTHERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NOVABONE PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORIENTAL RESOURCES DEVELOPMENT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOCON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHOGEM LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOGEM LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOREBIRTH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ORTHOVITA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
OSSDSIGN AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEONOVUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIONEER SURGICAL TECHNOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PIONEER SURGICAL TECHNOLOGY, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROGENTIX ORTHOBIOLOGY B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PROSIDYAN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROSIDYAN, INC |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
PROSIDYAN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SBM SCIENCES FOR BIO MATERIALS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEASPINE ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SIGNUS MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIRAKOSS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL KINETICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINESMITH PARTNERS, LLP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SURGENTEC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNERGY BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNERGY BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNERGY BIOMEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHES USA PRODUCTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TCM ASSOCIATES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTRIS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VIVORTE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WILTROM CORPORATION LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
XENCO MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XPAND BIOTECHNOLOGY BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZIMMER BIOMET SPINE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER KNEE CREATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Acumed LLC |
II |
Aug-23-2017 |
2 |
AlloSource, Inc. |
II |
May-06-2014 |
3 |
Apatech Limited |
II |
Jun-07-2016 |
4 |
Biocomposites, Ltd. |
II |
Dec-18-2020 |
5 |
Biostructures, LLC |
II |
Mar-16-2011 |
6 |
Bioventus, LLC |
II |
Apr-15-2019 |
7 |
Exactech, Inc. |
II |
May-29-2019 |
8 |
Globus Medical, Inc. |
II |
Oct-31-2013 |
9 |
Howmedica Osteonics Corp. |
II |
Dec-22-2018 |
10 |
Integra LifeSciences Corp |
II |
Feb-08-2012 |
11 |
Integra LifeSciences Corp |
II |
Mar-06-2009 |
12 |
Integra LifeSciences Corp. |
II |
Jun-12-2012 |
13 |
Medtronic Sofamor Danek USA Inc |
II |
Sep-08-2023 |
14 |
Musculoskeletal Transplant Foundation, Inc. |
II |
Feb-09-2024 |
15 |
Musculoskeletal Transplant Foundation, Inc. |
II |
Nov-17-2023 |
16 |
Musculoskeletal Transplant Foundation, Inc. |
II |
May-12-2021 |
17 |
Musculoskeletal Transplant Foundation, Inc. |
II |
Apr-17-2015 |
18 |
Nanotherapeutics, Inc |
II |
Dec-02-2011 |
19 |
Osteomed, LLC |
II |
May-29-2020 |
20 |
RTI Biologics, Inc. |
II |
Jun-23-2011 |
21 |
RTI Surgical, Inc. |
II |
Mar-10-2017 |
22 |
RTI Surgical, Inc. |
II |
Feb-07-2014 |
23 |
Skeletal Kinetics, Llc |
II |
Jul-15-2020 |
24 |
Skeletal Kinetics, Llc |
II |
Jul-24-2015 |
25 |
Surgical Tissue Network, Inc. |
II |
Jan-07-2013 |
26 |
Synthes (USA) Products LLC |
II |
Jun-09-2016 |
27 |
Synthes USA |
II |
Feb-15-2018 |
28 |
Synthes USA |
II |
Jan-11-2012 |
29 |
Theken Spine LLC |
II |
Sep-03-2009 |
|
|
|
|