Permamesh Hydroxylapatite Matrix
FDA 510(k) K960362 · Ceramed Corp.
510(k) numberK960362
Submission
- Device name
- Permamesh Hydroxylapatite Matrix
- Applicant
- Ceramed Corp.
Lakewood, CO, US - Received
- January 25, 1996
- Decision date
- March 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZK – Implant, Malar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code LZK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021419 | Aart Malar ImplantLZK · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | Implantech Associates, Inc. | 11/24/2000SE |
| K992240 | Pillar Malar ImplantLZK · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | Silimed, LLC | 07/09/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980139 | Spectrum Designs Profile Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K973502 | Implantech Conform Binder Submalar ImplantLZK · Traditional | Implantech Associates, Inc. | 11/07/1997SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962838 | Permaridge SyringeLYC · Traditional | 08/20/1996SE |
| K962786 | Osteograf Stainless Steel SyringLYC · Traditional | 08/01/1996SE |
| K960348 | OSTEOGRAF/N-300 HydroxylapatiteLYC · Traditional | 04/22/1996SE |
| K960368 | OSTEOGRAFT/N-700 HydroxylaptiteLYC · Traditional | 04/18/1996SE |
| K960353 | OSTEOGRAF/LD-300 HydroxylapatiteLYC · Traditional | 04/18/1996SE |
| K960361 | Permamesh-D Hydroxylapatite MatrixLYC · Traditional | 04/15/1996SE |
| K960354 | Permamesh-D Hydroxylapatite MatrixLZK · Traditional | 03/20/1996SE |
| K960349 | Permaridge Hydroxylapatite MatrixFWP · Traditional | 03/13/1996SE |
| K954631 | Osteograf/N-Blocck HydroxylapatiteLYC · Traditional | 01/02/1996SE |
| K942946 | OSTEOGRAF/D-100 HydroxylapatiteLYC · Traditional | 10/05/1994SE |
Questions and answers
When was Permamesh Hydroxylapatite Matrix cleared by the FDA?
Permamesh Hydroxylapatite Matrix (K960362) received a 510(k) decision of Substantially Equivalent on March 20, 1996, 55 days after the submission was received.
What is the product code of K960362?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.