Identity
- Trade Name
- Aequalis Resurfacing Head FDA UDI
- Generic Name
- Orthopaedic fixation plate tensioner FDA UDI
- Device Name
- KEELED COMPACTOR FDA UDI
- Model / Reference
- MWB491 FDA UDI
- Description
- KEELED COMPACTOR FDA UDI
Identifiers
- Catalog Number
- MWB491 FDA UDI
- Primary DI / UDI-DI
- 03700386970887 FDA UDI
- FDA Product Code
- HWN FDA UDI
- GMDN Term
- Orthopaedic fixation plate tensioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDI
Category: Orthopaedic fixation plate tensioner
Aequalis Resurfacing Head by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate tensioner.
- TENSIONER HEAD, CANNULATED — Biomet Orthopedics, Inc. · Class I
- LARGE FRAG TENSIONER — Biomet Orthopedics, Inc. · Class I
- Apelo® / Apelo® MIS — ATLAS SPINE INC. · Class I
- Tools - FPS — Trimed, INC. · Class I
- RIBFIX TITAN — BIOMET MICROFIXATION, INC · Class I
- Zimmer® Cable-Ready® System — Pioneer Surgical Technology, Inc. · Class I
- SMALL FRAG TENSIONER — Biomet Orthopedics, Inc. · Class I
- Apelo® / Apelo® MIS — ATLAS SPINE INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI 5556c823-bfc0-477f-ace8-2a372b2f333e 36 fields · synced Jun 1, 2026