Identity
- Trade Name
- PSN P-REF 4-IN-1 PEG FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- SSI005334 FDA UDI
Identifiers
- Catalog Number
- SSI005334 FDA UDI
- Primary DI / UDI-DI
- 00889024581616 FDA UDI
- 510(k) Number
- K142787 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
A comprehensive medical device directory, featuring the PSN P-REF 4-IN-1 PEG orthopaedic prosthesis implantation positioning instrument. This hand-held surgical instrument is designed to aid in the navigation/placement of prostheses or other instruments during implantation.
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
K142787 also covers:
- PSN 4-IN-1 W MOD SHELF — Zimmer, Inc.
- PSN 4-IN-1 W MOD SHELF — Zimmer, Inc.
- PSN 4-IN-1 W MOD SHELF — Zimmer, Inc.
- PSN 4-IN-1 W MOD SHELF — Zimmer, Inc.
- PSN 4-IN-1 W MOD SHELF — Zimmer, Inc.
- PSN A-Ref 4 In 1 W/SLTS — Zimmer, Inc.
- PSN A-Ref 4 In 1 W/SLTS — Zimmer, Inc.
- PSN A-Ref 4 In 1 W/SLTS — Zimmer, Inc.
- PSN A-Ref 4 In 1 W/SLTS — Zimmer, Inc.
- PSN A-Ref 4 In 1 W/SLTS — Zimmer, Inc.
- PSN HEX SHIFT BLOCK — Zimmer, Inc.
- PSN P-REF 4-IN-1 PEG — Zimmer, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI 4455a925-b967-468e-813b-3c6e7e6710cc 36 fields · synced Jul 14, 2026