FAT CONCENTRATION SYSTEM— 510(k) K100114

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K100114 for FAT CONCENTRATION SYSTEM, Substantially Equivalent on 2010-09-29. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MUU
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2010-01-15
Decision date: 2010-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUU

K210528 — IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit2022-03-16
K203800 — SyntrFuge System2021-07-02
K202443 — Smart Kit Basic, Smart Kit Pro2021-03-11
K193539 — REVOLVE ENVI 600 Advanced Adipose System2020-05-28
K193363 — Dermapose Refresh2020-04-14

More clearances from Biomet, Inc.

K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.