Identity
- Trade Name
- World Cup Size 62mm FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- 111-49-5062 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09348215065126 FDA UDI
- 510(k) Number
- K201278 FDA UDI
- FDA Product Code
- MEH FDA UDILPH FDA UDIKWZ FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 FDA UDI888.3310 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: Acetabular shell
World Cup Size 62mm 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
K201278 also covers:
- World 20° Hooded Liner Size 28A — SIGNATURE ORTHOPAEDICS PTY LTD
- World 20° Hooded Liner Size 28B — SIGNATURE ORTHOPAEDICS PTY LTD
- World 20° Hooded Liner Size 32B — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner - 10° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner - 10° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner - 20° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner - 20° Hood Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner - Neutral Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner – 10d Face Changing — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner – 10d Face Changing — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner – 10d Face Changing Vit-E — SIGNATURE ORTHOPAEDICS PTY LTD
- World Cup Liner – 10d Hood Lateralised — 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 5e66e23e-c00b-4ef5-a666-30c46903e2dd 33 fields · synced Jun 6, 2026