Identity
- Trade Name
- APEX Knee System FDA UDI
- Generic Name
- Orthopaedic bone calliper FDA UDI
- Device Name
- Patella Caliper FDA UDI
- Model / Reference
- KS-40101 FDA UDI
- Description
- Patella Caliper FDA UDI
Identifiers
- Catalog Number
- KS-40101 FDA UDI
- Primary DI / UDI-DI
- 00841690191414 FDA UDI
- FDA Product Code
- FTY FDA UDI
- GMDN Term
- Orthopaedic bone calliper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
No
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 calliper
APEX Knee System by OMNIlife science, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone calliper.
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- Novel — ALPHATEC SPINE, INC. · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- VerteFIT — Ldr Spine USA · Class I
- Perfix™ MIS — CG MedTech Co., Ltd. · 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
- OMNIlife science, Inc.
Sources (1)
- FDA UDI beaccdb1-6d47-48d1-ad0f-82eb9872d3a0 35 fields · synced Jun 9, 2026