LZK — Implant, Malar Class II
FDA product code LZK covers "Implant, Malar", a Class II medical device regulated under 21 CFR 878.3550. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZK
- Device Class
- Class II
- Regulation Number
- 878.3550
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K021419 | aesthetic and reconstructive technologies | AART MALAR IMPLANT | July 2, 2002 |
| K002886 | implantech associates | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | November 24, 2000 |
| K992240 | pillar surgical | PILLAR MALAR IMPLANT | November 22, 1999 |
| K983756 | surgical technology laboratories | SURGIFORM ANATOMICAL MALAR | November 20, 1998 |
| K982763 | seare biomedical | SEARE BIOMEDICAL MALAR IMPLANTS | September 30, 1998 |
| K981835 | silimed | SILIMED MALAR IMPLANT | July 9, 1998 |
| K980140 | spectrum designs | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | March 3, 1998 |
| K980141 | spectrum designs | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | March 3, 1998 |
| K980139 | spectrum designs | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | March 3, 1998 |
| K973502 | implantech associates | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | November 7, 1997 |
| K973574 | hanson medical | DURALASTIC ANATOMICAL MALAR IMPLANT | October 24, 1997 |
| K971479 | allied biomedical | DURALASTIC ANATOMICAL MALAR IMPLANTS | July 18, 1997 |
| K970400 | orthofix | BONE SOURCE HYDROXYAPATITE | May 2, 1997 |
| K964443 | surgical technology laboratories | SURGIFORM ANATOMICAL MALAR | December 20, 1996 |
| K962261 | implantech associates | IMPLANTECH WM NASAL-LABIAL IMPLANT | August 19, 1996 |
| K961511 | lifecore biomedical | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | June 28, 1996 |
| K961210 | w. l. gore and associates | SAM FACIAL IMPLANT | June 19, 1996 |
| K961080 | rand scientific | MEDIAL MALAR IMPLANT | April 19, 1996 |
| K960362 | ceramed | PERMAMESH HYDROXYLAPATITE MATRIX | March 20, 1996 |
| K960354 | ceramed | PERMAMESH-D HYDROXYLAPATITE MATRIX | March 20, 1996 |