PATIENT MATCHED TITANIUM ALLOY TROCHLEA— 510(k) K001350

Name: FDA 510(k) clearance K001350
Creator: U.S. Food and Drug Administration
Published: 2000-07-26

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K001350 for PATIENT MATCHED TITANIUM ALLOY TROCHLEA, Substantially Equivalent on 2000-07-26. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2000-04-28
Decision date: 2000-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRR

view all

K231253 — Overture Orthopaedics Patellofemoral System2023-07-07
K221048 — Episealer Patellofemoral System2022-12-23
K211303 — Avon Patello-femoral Joint Prosthesis2021-06-04
K200122 — MOTO PFJ System2020-04-20
K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty System2018-06-14

More clearances from Biomet, Inc.

view all

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.