Identity
- Trade Name
- Simplex FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Device Name
- Full Dose Bone Cement, 10 pack catalog number is 6191-1-010 FDA UDI
- Model / Reference
- 6191-1-001 FDA UDI
- Description
- Full Dose Bone Cement, 10 pack catalog number is 6191-1-010 FDA UDI
Identifiers
- Catalog Number
- 6191-1-001 FDA UDI
- Primary DI / UDI-DI
- 07613327128444 FDA UDI
- 510(k) Number
- K062553 FDA UDI
- FDA Product Code
- LOD FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 40.0 Gram FDA UDITotal Volume — 20.0 Milliliter FDA UDI
Category: Orthopaedic cement, non-antimicrobial
Simplex by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement, non-antimicrobial.
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Cleared under the same submission
K062553 also covers:
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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 508849b3-27d6-4351-9e71-5cc284f6b561 37 fields · synced May 30, 2026