Identity
- Trade Name
- SURESPACE FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Device Name
- FEMORAL SPACER MOLD MEDIUM FDA UDI
- Model / Reference
- SSF1067 FDA UDI
- Description
- FEMORAL SPACER MOLD MEDIUM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409043194 FDA UDI
- 510(k) Number
- K133449 FDA UDI
- FDA Product Code
- MBB FDA UDIJWH FDA UDI
- GMDN Term
- Orthopaedic cement spacer mould FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI888.3560 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
Dimensions & Sizes
- Size
- Length — 44 Millimeter FDA UDIWidth — 67 Millimeter FDA UDI
Category: Orthopaedic cement spacer mould
Surespace by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement spacer mould.
- Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
- STAGEONE — Biomet Orthopedics, Inc. · Class II
- StageOne Select — Biomet Orthopedics, Inc. · Class II
- CeMend 10-48 mold insert press — G21 SRL · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
- STAGEONE SELECT — Biomet Orthopedics, Inc. · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K133449 also covers:
- KASM — ORTHO DEVELOPMENT CORP.
- KASM — ORTHO DEVELOPMENT CORP.
- KASM — ORTHO DEVELOPMENT CORP.
- KASM — ORTHO DEVELOPMENT CORP.
- KASM — ORTHO DEVELOPMENT CORP.
- KASM — ORTHO DEVELOPMENT CORP.
- SURESPACE — ORTHO DEVELOPMENT CORP.
- SURESPACE — ORTHO DEVELOPMENT CORP.
- SURESPACE — ORTHO DEVELOPMENT CORP.
- SURESPACE — ORTHO DEVELOPMENT CORP.
- SURESPACE — ORTHO DEVELOPMENT CORP.
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
- Ortho Development Corp.
Sources (1)
- FDA UDI b6bb7ba1-baab-4466-85cd-272d916de90c 36 fields · synced May 30, 2026