|
Device |
arthroscope |
Definition |
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). |
Product Code | HRX |
Regulation Number |
888.1100
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
A.M. SURGICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED MEDICAL SYSTEMS GROUP SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AJU PHARM CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALTOMEC ENDOSCOPY INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAP ENDOSCOPIC PRODUCTS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AXIS SURGICAL TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYLIS MEDICAL CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOPSYBELL S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOVISION TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BLAZEJEWSKI MEDI-TECH GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CIT ORTHO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLARUS MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED LINVATEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORESPINE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DEPUY MITEK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
E SURGICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EBERLE GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EFS EBERLE FEINWERKTECHNISCHE SYSTEME |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELLIQUENCE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GALLINI MEDICAL DEVICES, SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HAND BIOMECHANICS LAB, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEMODIA S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEMODIA SAS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HOOGLAND SPINE PRODUCTS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HYDROCISION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMEDICOM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTEGRATED ENDOSCOPY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INTRAVU, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IZI MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CHANGMEI MEDTECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KARL STORZ ENDOSCOPY-AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAURIMED LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL VISION AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDISISS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDOS INTERNATIONAL, SARL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROAIRE SURGICAL INSTRUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROAIRE SURGICAL INSTRUMENTS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYELOTEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NLT SPINE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OK MEDINET KOREA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLYMPUS WINTER & IBE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIC SCIENCES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OUROBOROS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISTINE SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PROSURG, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RENOVO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RZ MEDIZINTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHOLLY FIBEROPTIC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL DYNAMICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPINAL DEVICES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINE VIEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRYKER ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TAEYEON MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THEKEN SPINE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSCORP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRICE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRICE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VERTIFLEX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERTOS MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISEON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VISIONSCOPE TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISIONSENSE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VISIONSENSE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.O.M. WORLD OF MEDICINE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEMED BIO-TECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-STEN CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
ADRIA SRL |
II |
Oct-19-2021 |
2 |
Ascent Healthcare Solutions |
II |
Feb-03-2012 |
3 |
Biomet, Inc. |
II |
May-26-2016 |
4 |
Biomet, Inc. |
II |
Mar-07-2011 |
5 |
Customed, Inc |
II |
Sep-03-2015 |
6 |
DePuy Mitek, Inc., a Johnson & Johnson Co. |
II |
Jan-15-2016 |
7 |
DePuy Mitek, Inc., a Johnson & Johnson Co. |
II |
Nov-08-2013 |
8 |
Instratek, Incorporated |
II |
Dec-22-2015 |
9 |
Linvatec Corp. dba ConMed Linvatec |
II |
Jul-10-2013 |
10 |
Linvatec Corp. dba ConMed Linvatec |
II |
Aug-24-2010 |
11 |
Linvatec Corp. dba ConMed Linvatec |
II |
Aug-09-2010 |
12 |
Linvatec Corp. dba ConMed Linvatec |
I |
Oct-01-2009 |
13 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-06-2024 |
14 |
Medical Vision Ab |
II |
Aug-30-2016 |
15 |
Medtronic Sofamor Danek USA Inc |
II |
Jun-16-2020 |
16 |
Medtronic Spine LLC (formerly Kyphon Inc.) |
II |
Sep-09-2011 |
17 |
Medtronic Spine LLC, formerly Kyphon Inc |
II |
May-11-2009 |
18 |
MicroAire Surgical Instruments, LLC |
II |
Aug-08-2019 |
19 |
MicroAire Surgical Instruments, LLC |
II |
May-25-2018 |
20 |
Myelotec, Inc. |
II |
Jul-28-2017 |
21 |
ReNovo, Inc. |
II |
Mar-02-2021 |
22 |
Richard Wolf GmbH |
II |
Aug-22-2018 |
23 |
Richard Wolf Medical Instruments Corp. |
II |
Feb-09-2016 |
24 |
Smith & Nephew, Inc. |
II |
Jul-24-2020 |
25 |
Smith & Nephew, Inc. Endoscopy Division |
II |
Sep-21-2009 |
26 |
Stryker Endoscopy |
II |
Jun-25-2014 |
27 |
Stryker Endoscopy |
II |
Apr-08-2011 |
28 |
Stryker Endoscopy |
II |
Dec-28-2010 |
29 |
Stryker Endoscopy |
II |
Jan-21-2009 |
30 |
Stryker Endoscopy |
II |
Jan-16-2009 |
31 |
Stryker GmbH |
II |
Aug-28-2019 |
32 |
Stryker GmbH |
II |
Jun-20-2019 |
33 |
Stryker Instruments Div. of Stryker Corporation |
II |
Mar-28-2018 |
34 |
Stryker Instruments Div. of Stryker Corporation |
II |
Nov-01-2013 |
35 |
Stryker Instruments Division of Stryker Corporation |
II |
Mar-28-2011 |
36 |
Stryker Sustainability Solutions |
II |
Mar-05-2019 |
37 |
Surgical Instrument Service And Savings, Inc. |
II |
Jul-01-2013 |
38 |
The Anspach Effort, Inc. |
II |
Jun-25-2014 |
39 |
WOM World Of Medicine AG |
II |
Jul-01-2024 |
40 |
Zimmer, Inc. |
II |
Apr-01-2013 |
|
|
|
|