LZK · Implant, Malar
General, Plastic Surgery · 21 CFR 878.3550 · Class 2
Overview
| Product Code | LZK |
|---|---|
| Device Name | Implant, Malar |
| Regulation | 21 CFR 878.3550 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K021419 | AART MALAR IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 2, 2002 | SESE |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Implantech Associates, Inc. | Nov 24, 2000 | SESE |
| K992240 | PILLAR MALAR IMPLANT | Pillar Surgical, Inc. | Nov 22, 1999 | SESE |
| K983756 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | Nov 20, 1998 | SESE |
| K982763 | SEARE BIOMEDICAL MALAR IMPLANTS | Seare Biomedical Corp. | Sep 30, 1998 | SESE |
| K981835 | SILIMED MALAR IMPLANT | Silimed, LLC | Jul 9, 1998 | SESE |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Spectrum Designs, Inc. | Mar 3, 1998 | SESE |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Spectrum Designs, Inc. | Mar 3, 1998 | SESE |
| K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | Spectrum Designs, Inc. | Mar 3, 1998 | SESE |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Implantech Associates, Inc. | Nov 7, 1997 | SESE |
| K973574 | DURALASTIC ANATOMICAL MALAR IMPLANT | Hanson Medical, Inc. | Oct 24, 1997 | SESE |
| K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | Allied Biomedical Corp. | Jul 18, 1997 | SESE |
| K970400 | BONE SOURCE HYDROXYAPATITE | Orthofix, Inc. | May 2, 1997 | SESE |
| K964443 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | Dec 20, 1996 | SESE |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | Implantech Associates, Inc. | Aug 19, 1996 | SESE |
| K961511 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | Jun 28, 1996 | SESE |
| K961210 | SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | Jun 19, 1996 | SESE |
| K961080 | MEDIAL MALAR IMPLANT | Rand Scientific Corp. | Apr 19, 1996 | SESE |
| K960362 | PERMAMESH HYDROXYLAPATITE MATRIX | Ceramed Corp. | Mar 20, 1996 | SESE |
| K960354 | PERMAMESH-D HYDROXYLAPATITE MATRIX | Ceramed Corp. | Mar 20, 1996 | SESE |
Top Applicants
- Implantech Associates, Inc. — 11 clearances
- Spectrum Designs, Inc. — 6 clearances
- Byron Medical — 3 clearances
- Surgical Technology Laboratories, Inc. — 2 clearances
- King & Spalding — 2 clearances
