Identity
- Trade Name
- RapidSorb FDA UDI
- Generic Name
- Craniofacial fixation plate, bioabsorbable FDA UDI
- Device Name
- 1.5MM RAPID RESORB CONTOURABLE MESH 100MM DIA/0.5MM THK-STER FDA UDI
- Model / Reference
- 851.652.01S FDA UDI
- Description
- 1.5MM RAPID RESORB CONTOURABLE MESH 100MM DIA/0.5MM THK-STER FDA UDI
Identifiers
- Catalog Number
- 85165201S FDA UDI
- Primary DI / UDI-DI
- 10887587064109 FDA UDI
- 510(k) Number
- K030069 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 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
Category: Craniofacial fixation plate, bioabsorbable
RapidSorb by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Craniofacial fixation plate, bioabsorbable.
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- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC · Class II
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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
- Synthes
Sources (1)
- FDA UDI 322ddd9c-e921-4f93-a8e3-30c1869b25a9 37 fields · synced May 31, 2026