AGEE-WRISTJACK PRE-DRILL KIT— 510(k) K942906
Substantially EquivalentHand Biomechanics Lab, Inc.
FDA 510(k) clearance K942906 for AGEE-WRISTJACK PRE-DRILL KIT, Substantially Equivalent on 1994-12-22. Applicant: Hand Biomechanics Lab, Inc.. Device class: 1.
Clearance details
- Applicant
- Hand Biomechanics Lab, Inc.
- Product code
- Code HTW
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code HTW
view allMore clearances from Hand Biomechanics Lab, Inc.
view all- K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
- K222490 — HBL Blade Assembly
- K181192 — PIP Fix
- K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
- K033112 — WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS
Adverse events under product code HTW
product code HTW- Injury
- 882
- Malfunction
- 8,544
- Other
- 3
- Total
- 9,429
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.