Identity
- Trade Name
- HYPE SCLA MINI FDA UDI
- Generic Name
- Press-fit femoral stem prosthesis FDA UDI
- Model / Reference
- HYPE SCLA 2 MINI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662200026098 FDA UDI
- FDA Product Code
- LZO FDA UDIMEH FDA UDI
- GMDN Term
- Press-fit femoral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
MR Conditional FDA UDI
Category: Press-fit femoral stem prosthesis
Hype Scla Mini by Soc Etudes Recherches Fabrication — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit femoral stem prosthesis.
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- Restoration — Howmedica Osteonics Corp. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- Accolade — Howmedica Osteonics Corp. · Class II
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
- Soc Etudes Recherches Fabrication
Sources (1)
- FDA UDI 0d93a2df-3afc-4e8f-81e8-52a2171c0b2f 32 fields · synced Jun 8, 2026