MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA— 510(k) K922489

Name: FDA 510(k) clearance K922489
Creator: U.S. Food and Drug Administration
Published: 1992-09-02

Substantially Equivalent

Porex Technologies Corp.

FDA 510(k) clearance K922489 for MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA, Substantially Equivalent on 1992-09-02. Applicant: Porex Technologies Corp.. Device class: 2.

Clearance details

Applicant: Porex Technologies Corp.
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1992-05-27
Decision date: 1992-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairburn, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FWP

view all

K254233 — MEDPOR Customized Implant Kit2026-03-12
K232593 — FITme Customized Silicone Implant2023-11-22
K200610 — Customized Contour Implant2020-12-23
K191130 — Customized Contour Implant2019-08-23
K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit2019-08-15

More clearances from Porex Technologies Corp.

view all

K971583 — MEDPOR OCULAR SCREW AND ACCEOSSORIES1997-06-30

Recalls naming K922489

K-number listed on FDA's recall record

Z-1090-2015 — MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.Class II·Terminated·Stryker Craniomaxillofacial Division·20141217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922489.

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