Identity
- Trade Name
- BIOSORB FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity FDA UDI
- Model / Reference
- OTIS 50 FDA UDI
- Description
- Wedge shaped implant for HTO - Absorbable calcium salt bone void filler 50% porosity FDA UDI
Identifiers
- Catalog Number
- P822367230 FDA UDI
- Primary DI / UDI-DI
- 03760154002097 FDA UDI
- 510(k) Number
- K071155 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDI
Biosorb by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 f7780e8c-f811-4dd3-b827-182e54cd5b99 38 fields · synced May 30, 2026