|
Device |
rod, fixation, intramedullary and accessories |
Product Code | HSB |
Regulation Number |
888.3020
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADAPTABLE ORTHO INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BAAT MEDICAL PRODUCTS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CITIEFFE S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONVENTUS ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOUBLE MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FH INDUSTRIE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOW-FX, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GPC MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOSYS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRA LIFESCIENCES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTRAUMA S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERETE GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOORTHO PRODUTOS ORTOPÉDICOS S/A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
ORTHO DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOPEDIATRICS, CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIATRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOXEL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PEGA MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
STRYKER TRAUMA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SYNTEC SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SYNTHES (USA) PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRUEMED GROUP LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WITTENSTEIN INTENS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-BOLT ORTHOPAEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-BOLT ORTHOPEDICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ZIMMER SWITZERLAND MANUFACTURING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2018 |
3526 |
3526 |
2019 |
2516 |
2516 |
2020 |
3299 |
3299 |
2021 |
4111 |
4111 |
2022 |
2726 |
2795 |
2023 |
1520 |
1520 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Biomet, Inc. |
II |
Jan-27-2023 |
2 |
Biomet, Inc. |
II |
Dec-17-2020 |
3 |
Flower Orthopedics Corporation |
II |
Jan-03-2022 |
4 |
Merete Medical GmbH |
II |
Nov-06-2020 |
5 |
NuVasive Specialized Orthopedics, Inc. |
II |
Dec-01-2021 |
6 |
Nuvasive Specialized Orthopedics Inc |
II |
Apr-05-2021 |
7 |
Nuvasive Specialized Orthopedics Inc |
II |
Mar-30-2021 |
8 |
Nuvasive Specialized Orthopedics Inc |
II |
Oct-07-2020 |
9 |
OrthoPediatrics Corp |
II |
Oct-25-2019 |
10 |
OrthoPediatrics Corp |
II |
Oct-13-2019 |
11 |
Pega Medical Inc. |
II |
Aug-14-2019 |
12 |
Smith & Nephew, Inc. |
II |
Aug-22-2023 |
13 |
Stryker GmbH |
II |
Jul-30-2021 |
14 |
Stryker GmbH |
II |
Jun-16-2020 |
15 |
Stryker GmbH |
II |
Aug-22-2018 |
16 |
Stryker GmbH |
II |
Jul-10-2018 |
17 |
Synthes (USA) Products LLC |
II |
Mar-10-2023 |
18 |
Synthes (USA) Products LLC |
II |
Feb-13-2018 |
19 |
Wright Medical Technology, Inc. |
II |
Nov-25-2019 |
20 |
Wright Medical Technology, Inc. |
II |
Apr-13-2018 |
21 |
Zimmer Biomet, Inc. |
II |
Nov-07-2019 |
22 |
Zimmer Biomet, Inc. |
II |
Nov-14-2018 |
23 |
Zimmer Biomet, Inc. |
II |
Oct-18-2018 |
24 |
Zimmer Biomet, Inc. |
II |
Sep-25-2018 |
25 |
Zimmer Biomet, Inc. |
II |
Sep-13-2018 |
26 |
Zimmer Biomet, Inc. |
II |
Apr-25-2018 |
27 |
Zimmer Biomet, Inc. |
II |
Apr-20-2018 |
28 |
Zimmer Biomet, Inc. |
II |
Mar-27-2018 |
29 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
30 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
31 |
Zimmer Biomet, Inc. |
II |
Jan-29-2018 |
32 |
Zimmer GmbH |
II |
Jun-04-2021 |
|
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