Panels › Orthopedic › Product code HXC · Class 1
Wrench
Regulation 888.4540
0510(k)s in 12 months (6 all time)
0recalls in 12 months (8 all time)
2recalls that name a 510(k)
Top companies in HXC
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet Spine, LLC | 0 | 2 |
| Med-Tool, Inc. | 2 | 0 |
| Aesculap, Inc. | 0 | 1 |
| Bradshaw Medical Inc. | 0 | 1 |
| DePuy Spine, Inc. | 0 | 1 |
| Gauthier Biomedical, Inc. | 1 | 0 |
| Jerome Medical | 1 | 0 |
| New Standard Device Inc | 0 | 1 |
| Orthofix, Inc | 0 | 1 |
| Truth, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2019 | New Standard Device Inc Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A Open, Classified |
HXC | K181630 |
| May 10, 2016 | Bradshaw Medical Inc. Axial Torque Limiting Driver (1st generation)
Product Usage:
The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) tor Terminated |
HXC | None listed |
| Feb 11, 2016 | Orthofix, Inc Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)
Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium). Terminated |
HXC | K151488 |
| Aug 3, 2015 | Aesculap, Inc. S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipita Terminated |
HXC | None listed |
| Apr 20, 2015 | Biomet Spine, LLC Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109
Product Usage:
Provides posterior fixation in the non-cervical spine with an interspinous fixation device. Terminated |
HXC | None listed |
| Apr 20, 2015 | Biomet Spine, LLC Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035
P_roduct Usage:
Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and var Terminated |
HXC | None listed |
| Jan 16, 2013 | DePuy Spine, Inc. DePuy Spine EXPEDIUM Offset Torque Wrench
Product Code 2797-29-510
The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. Terminated |
HXC | None listed |
| Mar 4, 2009 | Zimmer Inc. Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01.
Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silh Terminated |
HXC | None listed |
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