Identity
- Trade Name
- MONET FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Drill bit, Ø2.3 x L16mm, AO QC FDA UDI
- Model / Reference
- 113.7726 FDA UDI
- Description
- Drill bit, Ø2.3 x L16mm, AO QC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732127838 FDA UDI
- 510(k) Number
- K182151 FDA UDI
- FDA Product Code
- OVE FDA UDIODP FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
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
A comprehensive 2-3 paragraph SEO description written in clear, natural language. This device is a general internal orthopaedic fixation system implantation kit intended for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various metallic and/or plastic reusable devices, such as retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors, intended for the implantation of any type of internal orthopaedic fixation system.
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
Cleared under the same submission
K182151 also covers:
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
- MONET — CTL Medical Corporation
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
- CTL Medical Corporation
Sources (1)
- FDA UDI 4cf059bc-e380-46be-b448-807059c1ab3b 35 fields · synced Jul 24, 2026