Identity
- Trade Name
- Medicon Epiplating System FDA UDI
- Generic Name
- Orthopaedic fixation plate bending insert, reusable FDA UDI
- Device Name
- covering screw for hearing aid plates FDA UDI
- Model / Reference
- 68.80.43 FDA UDI
- Description
- covering screw for hearing aid plates FDA UDI
Identifiers
- Catalog Number
- 68.80.43 FDA UDI
- Primary DI / UDI-DI
- 04046826123710 FDA UDI
- 510(k) Number
- K241253 FDA UDI
- FDA Product Code
- FZE FDA UDI
- GMDN Term
- Orthopaedic fixation plate bending insert, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic fixation plate bending insert, reusable
Medicon Epiplating System by Medicon eG. Chirurgiemechaniker-Genossenschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate bending insert, reusable.
- Generic Instruments — Trimed, INC. · Class I
- ACUMED — ACUMED LLC · Class I
- ACUMED — ACUMED LLC · Class I
- FPS — Tyber Medical · Class I
- Holding and Bending Pins 2.5 – 2.8mm — BIOPRO, INC. · Class I
- FPS — Tyber Medical · Class I
- Holding and Bending Pin 3.0-3.5-4.0mm — BIOPRO, INC. · Class I
- Holding and Bending Pins 2.0 — BIOPRO, INC. · Class I
Cleared under the same submission
K241253 also covers:
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
- Medicon Epiplating System — Medicon eG. Chirurgiemechaniker-Genossenschaft
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon eG. Chirurgiemechaniker-Genossenschaft
Sources (1)
- FDA UDI 01825163-d780-41c6-8547-7163ee14e112 35 fields · synced Jun 1, 2026