Identity
- Trade Name
- "2.0/2.4MM" FRACTURE SYSTEM FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Model / Reference
- 24-1124 FDA UDI
Identifiers
- Catalog Number
- 24-1124 FDA UDI
- Primary DI / UDI-DI
- 00841036036102 FDA UDI
- 510(k) Number
- K121589 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic trocar blade, reusable
"2.0/2.4mm" Fracture System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic trocar blade, reusable.
- Trauma Fixation Systems — Biomet Orthopedics, Inc. · Class I
- LEVEL ONE TRANSBUCCAL — KLS-Martin L.P. · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
- Adapterkabel Touchproof für ALM Tube — inomed Medizintechnik GmbH · Class I
- EBA ONE — Citieffe · Class II
- Tympanon-Elektrode mit 1, 5mm Sicherheitsstecker — inomed Medizintechnik GmbH · Class I
- ARTHROLUTION — Richard Wolf GmbH · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
Cleared under the same submission
K121589 also covers:
- "1.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM — BIOMET MICROFIXATION, INC
- "1.5MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC
- "2.0MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC
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
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI aaeb6388-47da-40e7-8799-79e4148047fa 35 fields · synced May 30, 2026