Identity
- Trade Name
- SignaSure Poly FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Model / Reference
- 111-27-0236 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215031275 FDA UDI
- 510(k) Number
- K220495 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDI
- GMDN Term
- Non-constrained polyethylene 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: Non-constrained polyethylene acetabular liner
SignaSure Poly by Signature Orthopaedics Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-constrained polyethylene acetabular liner.
- C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
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- PRIME — MicroPort Orthopedics Inc. · Class II
- G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
- RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
- Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · Class II
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 4135c8fc-f832-449e-96fd-4b2915c93afe 33 fields · synced May 30, 2026