|
Device |
pin, fixation, smooth |
Product Code | HTY |
Regulation Number |
888.3040
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
4WEB MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
4WEB, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
A.M. SURGICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ADDITIVE ORTHOPAEDICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APEX TOOLS & ORTHOPEDICS CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AREX USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AREX USA LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARMIS BIOPHARMA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTHREX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARTHREX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
BIO2 TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMEDICAL ENT., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOMEDICAL ENTERPRISES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMET, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOPRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIORETEC LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONMED CORPORATION, LARGO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELECTRO-SPEC, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVERGREEN ORTHOPEDIC RESEARCH LAB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. (D.B.A.GRAMEDICA) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOWMEDICA OSTEONICS CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IN2BONES SAS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IN2BONES USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INION OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTELIVATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIMACORPORATE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDARTIS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEMOMETAL TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
METRIC MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEWCLIP TECHNICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEWDEAL SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVASTEP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOFIX SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHOHELIX SURGICAL DESIGNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ORTHOPEDIATRICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSSIO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
PACIFIC INSTRUMENTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28 |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAGON 28, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHALANX INNOVATIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRECIFIT MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESTOR3D |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKELETAL DYNAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMT SCHILLING METALLTECHNIK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL RESOURCES INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER TRAUMA GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNCHRO MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNTORR INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRILLIANT SURGICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TYBER MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERTICOR, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WISHBONE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WRIGHT MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
XIROS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZIMMER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Acumed LLC |
II |
Apr-25-2014 |
2 |
Amendia, Inc |
II |
Dec-22-2016 |
3 |
Biomet, Inc. |
II |
May-26-2016 |
4 |
Brasseler USA I Lp |
II |
Jan-29-2020 |
5 |
Brasseler USA, Medical L.L.C. |
II |
Mar-01-2022 |
6 |
MicroAire Surgical Instruments, LLC |
II |
Mar-03-2017 |
7 |
MicroAire Surgical Instruments, LLC |
II |
Sep-04-2013 |
8 |
Paragon 28, Inc. |
II |
Jul-27-2022 |
9 |
Smith & Nephew Inc |
II |
Aug-10-2010 |
10 |
Smith & Nephew, Inc. |
II |
Sep-19-2024 |
11 |
Stryker GmbH |
II |
Apr-27-2022 |
12 |
Synthes USA HQ, Inc. |
II |
Sep-18-2013 |
13 |
Trilliant Surgical, LLC |
II |
Apr-01-2020 |
14 |
Zimmer Biomet, Inc. |
II |
Jun-01-2018 |
15 |
Zimmer Biomet, Inc. |
II |
Oct-14-2016 |
16 |
Zimmer Inc. |
II |
Jun-26-2009 |
|
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