Identity
- Trade Name
- Percutaneous Compression Plate (PC.C.P) FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- GOTFRIED PC.C.P. FIXATION WIRE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- GOTFRIED PC.C.P. FIXATION WIRE FDA UDI
Identifiers
- Catalog Number
- 208000 FDA UDI
- Primary DI / UDI-DI
- 18032568866001 FDA UDI
- 510(k) Number
- K983814 FDA UDI
- FDA Product Code
- JDO FDA UDI
- GMDN Term
- Orthopaedic guidewire, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic guidewire, reusable
Percutaneous Compression Plate (PC.C.P) by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Orthopaedic Spreader — Synthes GmbH · Class IIa
- LCP — Synthes GmbH · Class IIa
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- VERTECEM — Synthes GmbH · Class IIa
- Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · Class I
Cleared under the same submission
K983814 also covers:
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — Orthofix, Inc.
- PERCUTANEOUS COMPRESSION PLATE (PC.C.P) — 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 a5365005-e3c4-474f-b98f-bb6a6b71464a 36 fields · synced Jun 6, 2026