Identity
- Trade Name
- Logical Dual Mobility CoCr Liner FDA UDI
- Generic Name
- Metallic acetabular liner FDA UDI
- Model / Reference
- 01-042-01-0241 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215112394 FDA UDI
- 510(k) Number
- K220495 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDI
- GMDN Term
- Metallic acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Metallic acetabular liner
Logical Dual Mobility CoCr Liner 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
K220495 also covers:
- Dual Mobility Logical Insert Trial — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Logical Insert Trial — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Logical Insert Trial — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Logical Insert Trial — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Logical Insert Trial — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — SIGNATURE ORTHOPAEDICS PTY LTD
- Dual Mobility Trial Head Sleeve — 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 a42c460a-6292-43c6-9d84-e03ae74e7b92 33 fields · synced Jun 8, 2026