ASCENSION NUGRIP CMC IMPLANT— 510(k) K112278

Name: FDA 510(k) clearance K112278
Creator: U.S. Food and Drug Administration
Published: 2011-11-04

Substantially Equivalent

Ascension Orthopedic

FDA 510(k) clearance K112278 for ASCENSION NUGRIP CMC IMPLANT, Substantially Equivalent on 2011-11-04. Applicant: Ascension Orthopedic. Device class: 2.

Clearance details

Applicant: Ascension Orthopedic
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2011-08-09
Decision date: 2011-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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
K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS2009-12-15
K061956 — ARTELON STT SPACER2007-06-07

More clearances from Ascension Orthopedic

view all

K140463 — INTEGRA EXTERNAL FIXATION SYSTEM2014-10-10
K131360 — INTEGRA TITANIUM BONE WEDGE2013-08-07
K130050 — TITAN REVERSE SHOULDER SYSTEM2013-06-18
K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEM2012-04-11
K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT2012-04-09

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