Identity
- Trade Name
- OTIS-C PLUS FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. FDA UDI
- Model / Reference
- NON STERILE Screw for OTIS-C PLUS plate fixation FDA UDI
- Description
- NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. FDA UDI
Identifiers
- Catalog Number
- EVONS66033 FDA UDI
- Primary DI / UDI-DI
- 03760154004695 FDA UDI
- 510(k) Number
- K120818 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 33 Millimeter FDA UDIOuter Diameter — 6.5 Millimeter FDA UDI
Otis-C Plus by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- S.b.m
Sources (1)
- FDA UDI 722e10a6-f52d-45a4-a8b4-111e9cd1ec65 38 fields · synced May 31, 2026