Identity
- Trade Name
- TOPS Inserter FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 82889 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115932638 FDA UDI
- PMA Number
- P220002 FDA UDI
- FDA Product Code
- QWK FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
TOPS Inserter by Premia Spine Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
- DJO SURGICAL — DJO, LLC · Class I
- ALEUTIAN Interbody Systems — K2M, INC. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- A/P Sizer, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- ARCADIUS XP C — AESCULAP, INC. · Class I
- LUCENT — SPINAL ELEMENTS, INC. · Class I
- U-KneeTec — CORIN LTD · Class II
- NCB® — Zimmer, Inc. · Class II
Cleared under the same submission
P220002 also covers:
- Alignment Gauge handle Long — PREMIA SPINE LTD
- Alignment Gauge handle Medium — PREMIA SPINE LTD
- Ball Probe — PREMIA SPINE LTD
- Ball Sleeve Assy — PREMIA SPINE LTD
- Cannulated Pedicle Awl — PREMIA SPINE LTD
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 5.5 mm — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Cannulated Tap Ø5.5 XL — PREMIA SPINE LTD
- Cannulated Tap Ø6.5 XL — PREMIA SPINE LTD
- Counter Torque — PREMIA SPINE LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premia Spine Ltd
Sources (1)
- FDA UDI be86333c-79ff-481e-b052-4adb2d854f63 33 fields · synced May 31, 2026