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510(k) K960362

PERMAMESH HYDROXYLAPATITE MATRIX by Ceramed Corp. — Product Code LZK

K960362 is an FDA 510(k) premarket notification submitted by Ceramed Corp. for the device "PERMAMESH HYDROXYLAPATITE MATRIX". The FDA issued a decision of Substantially Equivalent on March 20, 1996. The device falls under product code LZK (Implant, Malar), 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 20, 1996
Date Received
January 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Malar
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)
  • K960353 — OSTEOGRAF/LD-300 HYDROXYLAPATITE (April 18, 1996)
  • K960368 — OSTEOGRAFT/N-700 HYDROXYLAPTITE (April 18, 1996)
  • K960361 — PERMAMESH-D HYDROXYLAPATITE MATRIX (April 15, 1996)
  • K960354 — PERMAMESH-D HYDROXYLAPATITE MATRIX (March 20, 1996)
  • K960349 — PERMARIDGE HYDROXYLAPATITE MATRIX (March 13, 1996)
  • K954631 — OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE (January 2, 1996)
  • K942946 — OSTEOGRAF/D-100 HYDROXYLAPATITE (October 5, 1994)

Other clearances for product code LZK

  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

FDA data resources