Identity
- Trade Name
- Contours VPS Volar Plating System FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- FORCEPS, 6'' BONE REDUCTION FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- FORCEPS, 6'' BONE REDUCTION FDA UDI
Identifiers
- Catalog Number
- DH0461CE FDA UDI
- Primary DI / UDI-DI
- 18054242516279 FDA UDI
- 510(k) Number
- K101936 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, internal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic surgical distractor, internal
Contours VPS Volar Plating System by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic surgical distractor, internal.
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Cleared under the same submission
K101936 also covers:
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — Orthofix, Inc.
- Contours VPS Volar Plating System — 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 f7021c8f-f12a-45d0-8bb0-029b00ef02c6 36 fields · synced Jun 8, 2026