OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES— 510(k) K123908

Clearance details

Applicant

Matrix Surgical USA

Product code

Code KKY

Device class

Class 2

Regulation

21 CFR 878.3500

Advisory panel

General, Plastic Surgery

Date received

2012-12-19

Decision date

2013-07-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Alpharetta, GA, US

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• Z-1223-2019 — OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.Class II·Terminated·Matrix Surgical Holdings, LLC·20190130
• Z-1224-2019 — OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.Class II·Terminated·Matrix Surgical Holdings, LLC·20190130
• Z-1382-2017 — OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - RightClass II·Terminated·Matrix Surgical Holdings, LLC·20170125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123908.