Identity
- Trade Name
- Evolve Distal Centraliser FDA UDI
- Generic Name
- Femoral stem centralizer FDA UDI
- Model / Reference
- D111-162-003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215053772 FDA UDI
- 510(k) Number
- K133370 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Femoral stem centralizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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: Femoral stem centralizer
Evolve Distal Centraliser 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
K133370 also covers:
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- SKYLON Stem — Amplitude
- OrthoMedFlex — ORTHOMEDFLEX LLC
- OrthoMedFlex — ORTHOMEDFLEX LLC
- OrthoMedFlex — ORTHOMEDFLEX LLC
- OrthoMedFlex — ORTHOMEDFLEX LLC
- Paxeon BiPolar Head — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Signature Orthopaedics Pty Ltd
Sources (1)
- FDA UDI cb5145d9-9b0e-4405-a53f-7719b2c9321d 33 fields · synced May 30, 2026