Company ยท US
Hand Biomechanics Lab, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2025 | K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly Hand Biomechanics Lab, Inc. | HRX |
| Nov 14, 2022 | K222490 | HBL Blade Assembly Hand Biomechanics Lab, Inc. | HRX |
| Oct 22, 2018 | K181192 | PIP Fix Hand Biomechanics Lab, Inc. | JEC |
| Jan 9, 2008 | K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE Hand Biomechanics Lab, Inc. | JEC |
| Nov 5, 2003 | K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS Hand Biomechanics Lab, Inc. | KTT |
| Jun 10, 2003 | K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS Hand Biomechanics Lab, Inc. | JEC |
| Nov 8, 1999 | K992970 | DIGIT WIDGET Hand Biomechanics Lab, Inc. | JDW |
| Feb 12, 1999 | K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 Hand Biomechanics Lab, Inc. | JEC |
| Dec 22, 1994 | K942906 | AGEE-WRISTJACK PRE-DRILL KIT Hand Biomechanics Lab, Inc. | HTW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |