Identity
- Trade Name
- Tempus™ FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Temporary Fixation Pin FDA UDI
- Model / Reference
- 10-90-003 FDA UDI
- Description
- Temporary Fixation Pin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841508100799 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General internal orthopaedic fixation system implantation kit
Tempus is a General internal orthopaedic fixation system implantation kit designed for temporary placement of an internal orthopaedic fixation system into or onto all types of bones, including limbs, spine, pelvis, and craniomaxillofacial. It is a reusable device that includes various metallic and/or plastic instruments intended for the implantation of any type of internal orthopaedic fixation system. The Tempus system features a variety of instruments, including retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, and impactors.
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Neurostructures, Inc
Sources (1)
- FDA UDI 4a87c526-3d13-43ba-a82b-86e0e589ffb6 34 fields · synced Jun 29, 2026