SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS— 510(k) K111323

Name: FDA 510(k) clearance K111323
Creator: U.S. Food and Drug Administration
Published: 2011-11-16

Substantially Equivalent

Synthes, Inc.

FDA 510(k) clearance K111323 for SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS, Substantially Equivalent on 2011-11-16. Applicant: Synthes, Inc.. Device class: 2.

Clearance details

Applicant: Synthes, Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 2011-05-11
Decision date: 2011-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, 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
K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE2014-07-28

More clearances from Synthes, Inc.

view all

K131792 — SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY2013-12-16
K122647 — SYNTHES PATIENT SPECIFIC PLATE2013-02-28
K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM2012-11-19
K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM2012-08-23
K121574 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM2012-06-29

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