Identity
- Trade Name
- Synth-X SL FDA UDI
- Generic Name
- Vertebral bone filler, non-bioabsorbable FDA UDI
- Model / Reference
- HC-SX-SL FDA UDI
Identifiers
- Catalog Number
- HC-SX-SL FDA UDI
- Primary DI / UDI-DI
- 03760177046313 FDA UDI
- FDA Product Code
- NDN FDA UDI
- GMDN Term
- Vertebral bone filler, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Vertebral bone filler, non-bioabsorbable
Synth-X SL by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SpinePlex — Stryker Corp. · Class II
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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
- Teknimed
Sources (1)
- FDA UDI 976fcd6b-c202-4666-9ffa-dc03b33d3cfb 34 fields · synced May 30, 2026