ASCENSION PYROSPHERE (PCS)— 510(k) K042690

Name: FDA 510(k) clearance K042690
Creator: U.S. Food and Drug Administration
Published: 2004-11-13

Substantially Equivalent

Ascension Orthopedics, Inc.

FDA 510(k) clearance K042690 for ASCENSION PYROSPHERE (PCS), Substantially Equivalent on 2004-11-13. Applicant: Ascension Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Ascension Orthopedics, Inc.
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2004-09-29
Decision date: 2004-11-13
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
K112278 — ASCENSION NUGRIP CMC IMPLANT2011-11-04
K092548 — EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS2009-12-15

More clearances from Ascension Orthopedics, Inc.

view all

K233674 — Freedom Wrist Arthroplasty System2024-05-30
K233670 — Ascension Silicone MCP; Ascension Silicone PIP2023-12-14
K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM2013-02-13
K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM2011-12-06
K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY2010-12-21

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