|
Device |
fastener, fixation, nondegradable, soft tissue |
Product Code | MBI |
Regulation Number |
888.3040
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABANZA TECNOMED SL. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUITIVE TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AEVUMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AJU PHARM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AJU PHARM CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANIKA THERAPEUTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
20
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUXEIN MEDICAL PRIVATE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BAAT MEDICAL PRODUCTS B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CAYENNE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAYENNE MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONEXTIONS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
COUSIN BIOTECH S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSSROADS EXTREMITY SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DUNAMIS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FLOWER ORTHOPEDICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUSION ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GM DOS REIS INDUSTRIA E COMERICO LTDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTHIUM MEDTECH LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ICONN ORTHOPEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IN2BONES USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRITY ORTHOPAEDICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERNATIONAL LIFE SCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JARMON MEDICAL, LLC (DBA LEGENDS ORTHOPEDICS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KATOR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MARUHO MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDACTA INTERNATIONAL S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDACTA INTERNATIONAL SA |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
MEDOS INTERNATIONAL SARL |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
NVISION BIOMEDICAL TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO-DESIGN (PTY) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSTEONIC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
OXFORD PERFORMANCE MATERIALS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
PARAGON 28,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARCUS MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARCUS MEDICAL LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARCUS MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
RESPONSIVE ARTHROSCOPY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
RIVERPOINT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
RIVERPOINT MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RIVERPOINT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
S.B.M. SAS (SCIENCE & BIO MATERIALS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIGNATURE ORTHOPAEDICS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIMPARO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH & NEPHEW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STRYKER ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SUBCHONDRAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU ENDOPHIX CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
THE ORTHOPAEDIC IMPLANT COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIGON MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
U & I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALERIS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VALERIS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XIROS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YUNYI (BEIJING) MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2018 |
1072 |
1072 |
2019 |
1303 |
1303 |
2020 |
1453 |
1453 |
2021 |
1889 |
1889 |
2022 |
1586 |
1586 |
2023 |
1909 |
1909 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Arthrex, Inc. |
II |
Jan-11-2019 |
2 |
Biomet, Inc. |
II |
Dec-17-2020 |
3 |
OrthoPediatrics Corp |
II |
Jul-10-2020 |
4 |
Paragon 28, Inc. |
II |
Sep-22-2022 |
5 |
Smith & Nephew, Inc. |
II |
Jul-31-2020 |
6 |
Smith & Nephew, Inc. |
II |
Apr-22-2020 |
7 |
Smith & Nephew, Inc. |
II |
Feb-19-2020 |
8 |
Stryker Corporation |
II |
Sep-28-2023 |
9 |
Stryker Corporation |
II |
Mar-02-2020 |
10 |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
II |
Jul-03-2023 |
11 |
Valeris Medical, LLC |
II |
Oct-12-2018 |
12 |
Valeris Medical, LLC |
II |
Jul-13-2018 |
13 |
Zimmer Biomet, Inc. |
II |
Sep-26-2018 |
14 |
Zimmer Biomet, Inc. |
II |
Mar-15-2018 |
15 |
Zimmer Biomet, Inc. |
II |
Mar-14-2018 |
16 |
Zimmer Biomet, Inc. |
II |
Mar-01-2018 |
|
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|
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