HBL Blade Assembly— 510(k) K222490
Substantially EquivalentHand Biomechanics Lab, Inc.
FDA 510(k) clearance K222490 for HBL Blade Assembly, Substantially Equivalent on 2022-11-14. Applicant: Hand Biomechanics Lab, Inc.. Device class: 2.
Clearance details
- Applicant
- Hand Biomechanics Lab, Inc.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code HRX
view allMore clearances from Hand Biomechanics Lab, Inc.
view all- K252020 — TunnelVision Endoscopic Soft Tissue Release System and the 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
- K030519 — WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
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.