Home / 510(k) Clearances / K960349

510(k) K960349

PERMARIDGE HYDROXYLAPATITE MATRIX by Ceramed Corp. — Product Code FWP

K960349 is an FDA 510(k) premarket notification submitted by Ceramed Corp. for the device "PERMARIDGE HYDROXYLAPATITE MATRIX". The FDA issued a decision of Substantially Equivalent on March 13, 1996. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Ceramed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1996
Date Received
January 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Ceramed Corp.

  • K962838 — PERMARIDGE SYRINGE (August 20, 1996)
  • K962786 — OSTEOGRAF STAINLESS STEEL SYRING (August 1, 1996)
  • K960348 — OSTEOGRAF/N-300 HYDROXYLAPATITE (April 22, 1996)
  • K960368 — OSTEOGRAFT/N-700 HYDROXYLAPTITE (April 18, 1996)
  • K960353 — OSTEOGRAF/LD-300 HYDROXYLAPATITE (April 18, 1996)
  • K960361 — PERMAMESH-D HYDROXYLAPATITE MATRIX (April 15, 1996)
  • K960362 — PERMAMESH HYDROXYLAPATITE MATRIX (March 20, 1996)
  • K960354 — PERMAMESH-D HYDROXYLAPATITE MATRIX (March 20, 1996)
  • K954631 — OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE (January 2, 1996)
  • K942946 — OSTEOGRAF/D-100 HYDROXYLAPATITE (October 5, 1994)

Other clearances for product code FWP

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K232593 — FITme Customized Silicone Implant (November 22, 2023)
  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit (August 15, 2019)
  • K153508 — Stryker CMF MEDPOR Customized Implant (February 5, 2016)
  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)

FDA data resources