Identity
- Trade Name
- Tibial Trial Tray FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 122-18-0316 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215062071 FDA UDI
- 510(k) Number
- K190577 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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: Surgical implant template, reusable
Tibial Trial Tray by Signature Orthopaedics Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190577 also covers:
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Tibial Trial Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD
- World Knee System — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI cc791cc9-a979-4967-9266-5a3d8c693561 33 fields · synced Jun 1, 2026