FDA 510(k) Premarket Notification K080507: AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT

Submission Details & Decision

Normalized public record details for 510(k) notification K080507.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K080507

Applicant / Sponsor

Ceremed , Inc.

Device Name

AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT

Product Code

KKY

Decision Date

2008-04-21

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-02-25

Related Establishments / Registrations

BIOMET MICROFIXATION Registration: 1032347 View Registration
SURGICAL TECHNOLOGY LABORATORIES INC. Registration: 1825527 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
IMPLANTECH ASSOCIATES, INC. Registration: 2028924 View Registration
HOWMEDICA OSTEONICS CORP Registration: 2249697 View Registration
Synthes (USA) Products LLC Registration: 3008812560 View Registration
MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA Registration: 3009383407 View Registration
OXFORD PERFORMANCE MATERIALS, INC. Registration: 3009582362 View Registration
PORIFEROUS, LLC Registration: 3010781616 View Registration
Eurofins Infinity Laboratory Group Inc. Registration: 3013944123 View Registration
Longeviti Neuro Solutions Registration: 3014680740 View Registration

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