Identity
- Trade Name
- STAGEONE FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Model / Reference
- 432160 FDA UDI
Identifiers
- Catalog Number
- 432160 FDA UDI
- Primary DI / UDI-DI
- 00880304001831 FDA UDI
- FDA Product Code
- JWH FDA UDIMBB FDA UDI
- GMDN Term
- Orthopaedic cement spacer mould FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3027 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement spacer mould
Stageone by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement spacer mould.
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- Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
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Cleared under the same submission
K050210 also covers:
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
K161273 also covers:
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- STAGEONE — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
- StageOne™ — Biomet Orthopedics, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 966292ae-c502-4a05-9f06-7d7f5ea0c194 36 fields · synced Jun 1, 2026