Identity
- Trade Name
- Pennig Minifixator FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Device Name
- PMF THREADED WIRES D 1.6 MM STERILE LENGTH 70/15 MM (PACK OF 4) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- PMF THREADED WIRES D 1.6 MM STERILE LENGTH 70/15 MM (PACK OF 4) FDA UDI
Identifiers
- Catalog Number
- 99-M420 FDA UDI
- Primary DI / UDI-DI
- 18033509851919 FDA UDI
- 510(k) Number
- K955848 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic bone wire 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
Dimensions & Sizes
- Size
- Outer Diameter — 1.6 Millimeter FDA UDILength — 70 Millimeter FDA UDI
Category: Orthopaedic bone wire
Pennig Minifixator by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 7d6fa613-7fd1-4d6e-885d-b000fb0ea57c 37 fields · synced Jun 1, 2026