Identity
- Trade Name
- DISTRACTION SYSTEM FDA UDI
- Generic Name
- Implantable craniofacial bone distractor FDA UDI
- Model / Reference
- 915-3160 FDA UDI
Identifiers
- Catalog Number
- 915-3160 FDA UDI
- Primary DI / UDI-DI
- 00841036061081 FDA UDI
- 510(k) Number
- K002083 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Implantable craniofacial bone distractor 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
Yes
FDA UDI
Implantable
Yes
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: Implantable craniofacial bone distractor
Distraction System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable craniofacial bone distractor.
- DISTRACTION, INTERNAL, STERILE — KLS-Martin L.P. · Class II
- DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
- OsteoMed — Osteomed Corp. · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
- DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
- DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
- DISTRACTION, EXTERNAL — KLS-Martin L.P. · Class II
- DISTRACTION, INTERNAL — KLS-Martin L.P. · Class II
Cleared under the same submission
K002083 also covers:
- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 1.5 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — BIOMET MICROFIXATION, INC
- 2.0 LACTOSORB SYSTEM — 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 623bbd39-aac6-4342-b64f-bf7774c08b20 35 fields · synced May 30, 2026