Identity
- Trade Name
- Agee Digit Widget® FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- External fixation system for treatment of PIP joint flexion contractures. FDA UDI
- Model / Reference
- DWD-232 FDA UDI
- Description
- External fixation system for treatment of PIP joint flexion contractures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861994000212 FDA UDI
- 510(k) Number
- K992970 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone pin, non-bioabsorbable
Agee Digit Widget® by Hand Biomechanics Lab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
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- IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hand Biomechanics Lab, Inc.
Sources (1)
- FDA UDI e9e9b248-cb1f-4d4d-872b-aaf2df69c81c 35 fields · synced Jun 8, 2026