Identity
- Trade Name
- STAGEONE FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Model / Reference
- 432165 FDA UDI
Identifiers
- Catalog Number
- 432165 FDA UDI
- Primary DI / UDI-DI
- 00880304001183 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
A comprehensive medical device for treating joint arthroplasty infection, formed from antibiotic-containing bone cement that cures into the shape of a provisional joint prosthesis component.
Similar devices
Also classified as Orthopaedic cement spacer mould.
- Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
- SURESPACE — ORTHO DEVELOPMENT CORP. · Class II
- CeMend 10-48 mold insert press — G21 SRL · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
- Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
- SURESPACE — ORTHO DEVELOPMENT CORP. · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
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 4268c1f1-9bbb-4dc5-b1f6-21bf59c33526 36 fields · synced Jun 23, 2026