ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40— 510(k) K061451

Clearance details

Applicant

Ascension Orthopedics, Inc.

Product code

Code KYI

Device class

Class 2

Regulation

21 CFR 888.3770

Advisory panel

Orthopedic

Date received

2006-05-25

Decision date

2006-08-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061451.