Identity
- Trade Name
- Trial Liners (Neutral and 10 degree hooded) FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 112-152-166 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215038526 FDA UDI
- 510(k) Number
- K121297 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant template, reusable
Trial Liners (Neutral and 10 degree hooded) 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
K121297 also covers:
- Nifty Fifty VENTO Cup — Amplitude
- SIGNATURE Head - BIOLOX Delta — Amplitude
- SIROCCO Stem — Amplitude
- SIROCCO Stem — Amplitude
- SIROCCO Stem — Amplitude
- STRATUS Stem — Amplitude
- VENTO Cup — Amplitude
- VENTO Cup — Amplitude
- VENTO XLPE Liner — Amplitude
- VENTO XLPE Liner — Amplitude
- OrthoMedFlex — ORTHOMEDFLEX LLC
- Paxeon Aria — PAXEON RECONSTRUCTION LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI efe18b1e-4d7c-4f5d-8b67-c8b7b3712315 33 fields · synced Jun 6, 2026