MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507— 510(k) K052596

Name: FDA 510(k) clearance K052596
Creator: U.S. Food and Drug Administration
Published: 2005-11-15

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K052596 for MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507, Substantially Equivalent on 2005-11-15. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant: Biopro, Inc.
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2005-09-21
Decision date: 2005-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYI

view all

K201072 — Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 1612020-12-02
K180744 — Stablyx CMC Arthroplasty Implant System2018-04-11
K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 52011-12-30
K112278 — ASCENSION NUGRIP CMC IMPLANT2011-11-04
K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS2009-12-15

More clearances from Biopro, Inc.

view all

K163627 — Shotel Ankle Arthrodesis Nail System2017-09-14
K162674 — BioPro Foot Plating Systems2017-06-16
K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEM2013-10-24
K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM2013-06-18
K121973 — BIOPRO HEMI-EDGE TOE SYSTEM2012-10-30

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