Identity
- Trade Name
- TOPS™ - 21 S FDA UDI
- Generic Name
- Posterior lumbar spine prosthesis FDA UDI
- Device Name
- The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression. FDA UDI
- Model / Reference
- 86000 FDA UDI
- Description
- The TOPS™ device is a motion preserving spinal implant that is inserted into the lumbar spine via pedicle screws. The device is implanted via a posterior surgical approach to replace the degenerated skeletal elements such as the lamina and the facet joints that are removed during the decompression. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290014064027 FDA UDI
- FDA Product Code
- QWK FDA UDI
- GMDN Term
- Posterior lumbar spine prosthesis FDA UDI
Classification
- Device Class
- Class III 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: Posterior lumbar spine prosthesis
Tops™ - 21 S by Premia Spine Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Posterior lumbar spine prosthesis.
- Zavation — ZAVATION · Class II
- Zavation — ZAVATION · Class II
- Zavation — ZAVATION · Class II
- TOPS™ - 21 M — PREMIA SPINE LTD · Class III
- TOPS™ - 21 L — PREMIA SPINE LTD · Class III
- TOPS™ - 30 L — PREMIA SPINE LTD · Class III
- TOPS™ - 38 L — PREMIA SPINE LTD · Class III
- TOPS™ - 30 S — PREMIA SPINE LTD · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Premia Spine Ltd
Sources (1)
- FDA UDI fa4fa09d-968b-4bae-ad3a-cc4411c404ab 34 fields · synced Jun 1, 2026