FDA Product Code
FDA Product Code LZK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3550
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021419 | AART MALAR IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | Traditional | PDF ↗ |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Implantech Associates, Inc. | 2000-11-24 | Traditional | PDF ↗ |
| K992240 | PILLAR MALAR IMPLANT | Pillar Surgical, Inc. | 1999-11-22 | Traditional | PDF ↗ |
| K983756 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | 1998-11-20 | Special | PDF ↗ |
| K982763 | SEARE BIOMEDICAL MALAR IMPLANTS | Seare Biomedical Corp. | 1998-09-30 | Traditional | PDF ↗ |
| K981835 | SILIMED MALAR IMPLANT | Silimed, LLC | 1998-07-09 | Traditional | PDF ↗ |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 | Traditional | PDF ↗ |
| K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 | Traditional | PDF ↗ |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 | Traditional | PDF ↗ |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Implantech Associates, Inc. | 1997-11-07 | Traditional | PDF ↗ |
| K973574 | DURALASTIC ANATOMICAL MALAR IMPLANT | Hanson Medical, Inc. | 1997-10-24 | Traditional | PDF ↗ |
| K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | Allied Biomedical Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K970400 | BONE SOURCE HYDROXYAPATITE | Orthofix, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K964443 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | Implantech Associates, Inc. | 1996-08-19 | Traditional | PDF ↗ |
| K961511 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1996-06-28 | Traditional | PDF ↗ |
| K961210 | SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K961080 | MEDIAL MALAR IMPLANT | Rand Scientific Corp. | 1996-04-19 | Traditional | PDF ↗ |
| K960354 | PERMAMESH-D HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-20 | Traditional | PDF ↗ |
| K960362 | PERMAMESH HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-20 | Traditional | PDF ↗ |
| K943988 | IMPLANTECH NASAL LABIAL IMPLANT | Implantech Associates, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K944165 | SILHOUETTE MALAR IMPLANT | Spectrum Designs, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K944164 | MENISCUS CHIN IMPLANT | Spectrum Designs, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K944166 | DORSAL COLUMELLA IMPLANT | Spectrum Designs, Inc. | 1994-11-04 | Traditional | PDF ↗ |
| K942421 | IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT | King & Spalding | 1994-08-08 | Traditional | PDF ↗ |
| K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | King & Spalding | 1994-08-08 | Traditional | PDF ↗ |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | Byron Medical | 1994-02-03 | Traditional | PDF ↗ |
| K921582 | FLOWERS MEDIAL MALAR IMPLANT | Implantech Associates, Inc. | 1992-05-06 | Traditional | PDF ↗ |
| K914016 | ZARA ZONE IV MALAR IMPLANT | Byron Medical | 1991-12-05 | Traditional | PDF ↗ |
| K911513 | TRAPEZOIDAL MALAR IMPLANT | Implantech Associates, Inc. | 1991-07-01 | Traditional | PDF ↗ |
| K911515 | EXTENDED MALAR IMPLANT | Implantech Associates, Inc. | 1991-07-01 | Traditional | PDF ↗ |
| K910655 | COMBINED MALAR IMPLANT | Implantech Associates, Inc. | 1991-03-28 | Traditional | PDF ↗ |
| K904348 | CUI FEATHERED SILICONE MALAR | Cui Corp. | 1990-11-26 | Traditional | PDF ↗ |
| K902284 | ZYMALAR IMPLANT | Applied Biomaterial Technologies | 1990-09-12 | Traditional | PDF ↗ |
| K903329 | CUI ANATOMICAL SILICONE MALAR | Cui Corp. | 1990-09-10 | Traditional | PDF ↗ |
| K901662 | ANATOMICAL MALAR IMPLANT | Implantech Associates, Inc. | 1990-05-01 | Traditional | PDF ↗ |
| K895152 | BINDER SUBMALAR FACIAL IMPLANT II | Implantech Associates, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K894493 | BINDER SUBMALAR FACIAL IMPLANT | Implantech Associates, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K873434 | CREAT BRAND MALAR IMPLANT | Aesthetech Corp. | 1987-09-11 | Traditional | PDF ↗ |
| K863400 | BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR | Byron Medical | 1986-09-17 | Traditional | PDF ↗ |
Product code LZK · Class II · General, Plastic Surgery. Data: openFDA.