Hand Biomechanics Lab Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0136-2017 | Class II | Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction | September 14, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | October 15, 2025 |
| K222490 | HBL Blade Assembly | November 14, 2022 |
| K181192 | PIP Fix | October 22, 2018 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | January 9, 2008 |
| K033112 | WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS | November 5, 2003 |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | June 10, 2003 |
| K992970 | DIGIT WIDGET | November 8, 1999 |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 | February 12, 1999 |
| K942906 | AGEE-WRISTJACK PRE-DRILL KIT | December 22, 1994 |