Identity
- Trade Name
- World Knee Asymmetrical Patella Vit-E FDA UDI
- Generic Name
- Polyethylene patella prosthesis FDA UDI
- Model / Reference
- 121-20-8210E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215134358 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDI
- GMDN Term
- Polyethylene patella prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
Yes
FDA UDI
Category: Polyethylene patella prosthesis
World Knee Asymmetrical Patella Vit-E by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181530 also covers:
- All Poly Monotrial UC — SIGNATURE ORTHOPAEDICS PTY LTD
- All Poly Monotrial UC — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee Asymmetrical Patella Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee Asymmetrical Patella Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee Asymmetrical Patella – Finned Peg — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee Asymmetrical Patella – Finned Peg Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee CR All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee PS All Poly Tibia — SIGNATURE ORTHOPAEDICS PTY LTD
K241690 also covers:
- Logical 10d Face Changing Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 10d Face Changing Liner Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical Cup Liner - 10° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical Cup Liner - 10° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical Cup Liner - 10° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
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
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI 517187b8-da4c-4e9c-95e6-0e7d51966617 33 fields · synced May 30, 2026