Identity
- Trade Name
- SynCage FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- SYNCAGE®-OPEN ANTEROLATERAL 11MM (TI) FDA UDI
- Model / Reference
- 495.271 FDA UDI
- Description
- SYNCAGE®-OPEN ANTEROLATERAL 11MM (TI) FDA UDI
Identifiers
- Catalog Number
- 495271 FDA UDI
- Primary DI / UDI-DI
- 10705034784984 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 cc8fdbd1-5b5e-4040-bbc3-60137a6c4618 36 fields · synced Jun 1, 2026