|
Device |
orthosis, spinal pedicle fixation |
Product Code | MNI |
Regulation Number |
888.3070
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A-SPINE ASIA, CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCEL SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALPHATEC SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ALTUS PARTNERS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTECHNI AMERICA SPINE GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAPTIVA SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CG BIO CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORE-NEXUS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORELINK LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORENTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEPUY SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOUBLE MEDICAL TECHNOLOGY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMINENT SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXACTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVATIVE SURGICAL DESIGNS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
K2M, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
K7 LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KISCO INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOREA BONE BANK CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L & K BIOMED CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
L&K BIOMED CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LANX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE USA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIFE SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDACTA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICREA INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDICREA TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDYSSEY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MIGHTY OAK MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIKRON MAKINA SANAYI TICARET CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIKRON MAKINA SANAYI VE TICARET LTD STI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW ERA ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEW ERA ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXXT SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OSTEOMED IMPLANTES, LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHYGEN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECISION SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RELIANCE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
RENOVIS SURGICAL TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROBERT REID INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAVANNAH TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINTEA PLASTEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOLCO BIOMEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL USA |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SPINE ART |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE WAVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
SPINE360 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K102995 TALON SPINAL SYSTEM
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SPINEFRONTIER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEVISION, S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTHES SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Blackstone Medical, Inc. |
II |
Mar-16-2010 |
2 |
Blackstone Medical, Inc. |
II |
Jul-06-2009 |
3 |
CTL Medical Corporation |
II |
Mar-20-2019 |
4 |
Captiva Spine, Inc |
II |
Nov-21-2012 |
5 |
EBI, L.P. |
III |
Sep-22-2009 |
6 |
Exactech, Inc. |
II |
Mar-18-2014 |
7 |
Medicrea International |
II |
Aug-24-2023 |
8 |
New Era Orthopaedics, LLc |
II |
Aug-03-2018 |
9 |
Orthopedic Alliance LLC |
II |
Apr-22-2013 |
10 |
Spinal Solutions, LLC |
II |
May-27-2013 |
11 |
SpineFrontier, Inc. |
II |
Dec-20-2013 |
12 |
SpineFrontier, Inc. |
II |
Dec-19-2013 |
13 |
SpineFrontier, Inc. |
II |
Jul-16-2013 |
14 |
Stryker Spine |
II |
Aug-22-2012 |
15 |
Stryker Spine |
II |
Apr-10-2009 |
16 |
Synthes (USA) Products LLC |
II |
Oct-17-2015 |
17 |
Synthes (USA) Products LLC |
II |
Jul-20-2012 |
18 |
Synthes USA HQ, Inc. |
II |
Aug-09-2013 |
19 |
Valorem Surgical LLC |
II |
Aug-10-2017 |
20 |
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK |
II |
Mar-12-2009 |
21 |
Zimmer Inc. |
II |
Aug-31-2010 |
|
|
|
|