OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE— 510(k) K133809

Name: FDA 510(k) clearance K133809
Creator: U.S. Food and Drug Administration
Published: 2014-07-28

Substantially Equivalent

Oxford Performance Materials

FDA 510(k) clearance K133809 for OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE, Substantially Equivalent on 2014-07-28. Applicant: Oxford Performance Materials. Device class: 2.

Clearance details

Applicant: Oxford Performance Materials
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 2013-12-16
Decision date: 2014-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Windsor, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKY

view all

K211514 — Longeviti PorousFit implant2021-07-15
K161052 — OsteoFab Patient Specific Facial Device2016-07-20
K160988 — Biopor, AOC Porous Polyethylene, Cerepor2016-07-14
K141880 — BIOPOR AOC POROUS POLYETHYLENE, CEREPOR2015-04-16
K140437 — SU-POR SURGICAL IMPLANT2014-06-13

More clearances from Oxford Performance Materials

view all

K142005 — SpineFab Vertebral Body Replacement (VBR) System2015-07-10
K121818 — OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE2013-02-07

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