Identity
- Trade Name
- MIS reduction Tool reducer FDA UDI
- Generic Name
- Orthopaedic bone-reduction tool FDA UDI
- Model / Reference
- 86500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290115934403 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDINKB FDA UDI
- GMDN Term
- Orthopaedic bone-reduction tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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 bone-reduction tool
MIS reduction Tool reducer by Premia Spine Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone-reduction tool.
- TRIGEN MAX — Smith & Nephew, Inc. · Class II
- REDUCTION TOOL SMALL BONE NAIL — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
- Tools - WFS (C) — Trimed, INC. · Class I
- TRIGEN — Smith & Nephew, Inc. · Class II
- PRECICE® Trauma Nail System — NuVasive Specialized Orthopedics, Inc. · Class I
- Reduction Rod — Double Medical Technology Inc. · Class II
- MULTILOC — Synthes · Class II
- TRIGEN — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K150380 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — PREMIA SPINE LTD
- Head Releaser — PREMIA SPINE LTD
- Inner Dilator — PREMIA SPINE LTD
- K-Wire, Blunt Beveled Tip, L=335, Ø 1.7 mm KWA — PREMIA SPINE LTD
- MIS Cannulated Pedicle Probe — PREMIA SPINE LTD
- MIS Compressor — PREMIA SPINE LTD
K170061 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — PREMIA SPINE LTD
- Head Releaser — PREMIA SPINE LTD
- Inner Dilator — PREMIA SPINE LTD
- K-Wire, Blunt Beveled Tip, L=335, Ø 1.7 mm KWA — PREMIA SPINE LTD
- K-Wire, Blunt Blunt Tip, L=600, Ø1.7mm P.Drill — PREMIA SPINE LTD
- K-Wire, Blunt Sharp Tip, L=335, Ø1.7mm KWA — PREMIA SPINE LTD
K231844 also covers:
- Cannulated Screwdriver — PREMIA SPINE LTD
- Cannulated Screwdriver short — PREMIA SPINE LTD
- Cannulated Tap Ø 6.5 mm — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Cannulated Tapered Pedicle Screw — PREMIA SPINE LTD
- Compressor — PREMIA SPINE LTD
- Distractor — PREMIA SPINE LTD
- Distractor for Open Procedure — PREMIA SPINE LTD
- Fix connector power drill adaptor — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Premia Spine Ltd
Sources (1)
- FDA UDI 9234038b-5e2e-4daf-8268-b081358a60d8 33 fields · synced May 30, 2026