Identity
- Trade Name
- Lateralised 20 Hood Trial Liner : SIZE 36/52-54mm FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Model / Reference
- 112-15-9652 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215072933 FDA UDI
- 510(k) Number
- K153131 FDA UDI
- FDA Product Code
- LPH FDA UDIMEH FDA UDIKWZ FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI888.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Category: Surgical implant template, reusable
Lateralised 20 Hood Trial Liner : SIZE 36/52-54mm 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
K153131 also covers:
- VENTO XLPE Liner — Amplitude
- VENTO XLPE Liner — Amplitude
- VENTO XLPE Liner — Amplitude
- Basic Sterilization Caddy - Logical Upper — SIGNATURE ORTHOPAEDICS PTY LTD
- LC Instrument Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- LC Instrument Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- LC Instrument Tray — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD
- Logical 20° Hooded Liner — 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 0628c039-61c9-424d-b874-74e69add688b 33 fields · synced Jun 1, 2026