Identity
- Trade Name
- Radiolucent Wrist Fixator FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use, sterile FDA UDI
- Device Name
- RADIOLUCENT WRIST FIXATOR KIT STERILE, WITH COATED SCREWS FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- RADIOLUCENT WRIST FIXATOR KIT STERILE, WITH COATED SCREWS FDA UDI
Identifiers
- Catalog Number
- SS99-36502 FDA UDI
- Primary DI / UDI-DI
- 18032568866384 FDA UDI
- 510(k) Number
- K955848 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use, sterile 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
No
FDA UDI
Contains Latex
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External orthopaedic fixation system, single-use, sterile
Radiolucent Wrist Fixator by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use, sterile.
- DOLPHIX — Citieffe · Class II
- FastFrame™ — Zimmer, Inc. · Class II
- DFS HA BONE SCREWS — Biomet Orthopedics, Inc. · Class II
- DOLPHIX — Citieffe · Class II
- DOLPHIX — Citieffe · Class II
- DOLPHIX — Citieffe · Class II
- DOLPHIX — Citieffe · Class II
- FastFrame® — Zimmer, Inc. · Class II
Cleared under the same submission
K955848 also covers:
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
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
- Orthofix, Inc.
Sources (1)
- FDA UDI 28e884d5-455f-4acd-afb7-27d322772ec7 36 fields · synced May 31, 2026