Panels › Orthopedic › Product code JEC · Class 2
Component, Traction, Invasive
Regulation 888.3040
0510(k)s in 12 months (85 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in JEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Howmedica Corp. | 13 | 0 |
| Ace Orthopedic Manufacturing Co. | 5 | 0 |
| Hand Biomechanics Lab, Inc. | 4 | 1 |
| Synthes (Usa) | 4 | 0 |
| Acu Med, Inc. | 3 | 0 |
| Anjon Holdings, LLC | 2 | 1 |
| Jerome Medical | 3 | 0 |
| Ace Medical Co. | 2 | 0 |
| Autogenesis, Inc. | 2 | 0 |
| Buckman Co., Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2020 | Anjon Holdings Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and the Terminated |
JEC | K193256 |
| Nov 21, 2019 | Stryker GmbH Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm
Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) Terminated |
JEC | K102885 |
| Jun 21, 2018 | Ossur Americas Ossur Skull Pin, Sterile Titanium Pin,
Part/Description:
516TS/ Skull Pin 2-1/4in TI Sterl 1PK;
516V2S/ Skull Pin 3in TI Sterl 1PK;
520TS/ Skull Pin 2-1/4in TI Sterl 5PK;
520V2S/ Skull Pin 3in TI St Terminated |
JEC | K822780 |
| Sep 14, 2016 | Hand Biomechanics Lab Inc Agee-WristJack Fracture Reduction System;
Item number: CFD-147.
The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. T Terminated |
JEC | K984442 |
| Mar 16, 2010 | Acumed LLC Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed Terminated |
JEC | K965029 |
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures. Terminated |
JEC | K971755 |
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