Identity
- Trade Name
- SynCage FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- SYNCAGE®-SMALL PARALLEL 12MM (TI) FDA UDI
- Model / Reference
- 495.822 FDA UDI
- Description
- SYNCAGE®-SMALL PARALLEL 12MM (TI) FDA UDI
Identifiers
- Catalog Number
- 495822 FDA UDI
- Primary DI / UDI-DI
- 10705034786544 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
SynCage by Synthes (u.s.a.) Lp — 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
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI f1dfa72a-b711-4f39-8d88-da98c7a22f6a 36 fields · synced Jun 1, 2026