Identity
- Trade Name
- Apex FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- Apex Tibial Screw, Sterile FDA UDI
- Model / Reference
- LS01-50035 FDA UDI
- Description
- Apex Tibial Screw, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391529580148 FDA UDI
- 510(k) Number
- K170972 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
Apex by Orthoxel Designated Activity Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- A.L.P.S.CORTICAL SCREW — Biomet Orthopedics, Inc. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K170972 also covers:
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 |
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Manufacturer
- Manufacturer
- Orthoxel Designated Activity Company
Sources (1)
- FDA UDI f798e7e3-a689-4751-9c08-bdcbb6d87d93 37 fields · synced May 30, 2026