Identity
- Trade Name
- Silicone PIP FDA UDI
- Generic Name
- Proximal interphalangeal joint prosthesis, one-piece FDA UDI
- Device Name
- Silicone PIP SZ 4 FDA UDI
- Model / Reference
- SPIP-520-4-WW FDA UDI
- Description
- Silicone PIP SZ 4 FDA UDI
Identifiers
- Catalog Number
- SPIP-520-4-WW FDA UDI
- Primary DI / UDI-DI
- 00885556858530 FDA UDI
- FDA Product Code
- KYJ FDA UDI
- GMDN Term
- Proximal interphalangeal joint prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3230 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Proximal interphalangeal joint prosthesis, one-piece
Silicone PIP by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Proximal interphalangeal joint prosthesis, one-piece.
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- Silicone PIP — Smith & Nephew, Inc. · Class II
- Silicone PIP — Smith & Nephew, Inc. · Class II
- Silicone PIP — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K082231 also covers:
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Ascension® Silicone PIP — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
- Integra® — Ascension Orthopedics, Inc.
K233670 also covers:
- Silicone MCP — Smith & Nephew, Inc.
- Silicone MCP — Smith & Nephew, Inc.
- Silicone MCP — Smith & Nephew, Inc.
- Silicone MCP — Smith & Nephew, Inc.
- Silicone MCP — Smith & Nephew, Inc.
- Silicone MCP — Smith & Nephew, Inc.
- Silicone PIP — Smith & Nephew, Inc.
- Silicone PIP — Smith & Nephew, Inc.
- Silicone PIP — Smith & Nephew, Inc.
- Silicone PIP — Smith & Nephew, Inc.
- Silicone PIP — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 32173830-2fad-4e4b-89e4-1123d48428b3 36 fields · synced Jun 8, 2026