Product code LZK
- Device name
- Implant, Malar
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3550
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K021419 | AART MALAR IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | Implantech Associates, Inc. | 2000-11-24 |
| K992240 | PILLAR MALAR IMPLANT | Pillar Surgical, Inc. | 1999-11-22 |
| K983756 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | 1998-11-20 |
| K982763 | SEARE BIOMEDICAL MALAR IMPLANTS | Seare Biomedical Corp. | 1998-09-30 |
| K981835 | SILIMED MALAR IMPLANT | Silimed, LLC | 1998-07-09 |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 |
| K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | Spectrum Designs, Inc. | 1998-03-03 |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Implantech Associates, Inc. | 1997-11-07 |
| K973574 | DURALASTIC ANATOMICAL MALAR IMPLANT | Hanson Medical, Inc. | 1997-10-24 |
| K971479 | DURALASTIC ANATOMICAL MALAR IMPLANTS | Allied Biomedical Corp. | 1997-07-18 |
| K970400 | BONE SOURCE HYDROXYAPATITE | Orthofix, Inc. | 1997-05-02 |
| K964443 | SURGIFORM ANATOMICAL MALAR | Surgical Technology Laboratories, Inc. | 1996-12-20 |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | Implantech Associates, Inc. | 1996-08-19 |
| K961511 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1996-06-28 |
| K961210 | SAM FACIAL IMPLANT | W. L. Gore & Associates, Inc. | 1996-06-19 |
| K961080 | MEDIAL MALAR IMPLANT | Rand Scientific Corp. | 1996-04-19 |
| K960354 | PERMAMESH-D HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-20 |
| K960362 | PERMAMESH HYDROXYLAPATITE MATRIX | Ceramed Corp. | 1996-03-20 |
| K943988 | IMPLANTECH NASAL LABIAL IMPLANT | Implantech Associates, Inc. | 1995-01-27 |
| K944164 | MENISCUS CHIN IMPLANT | Spectrum Designs, Inc. | 1994-11-04 |
| K944165 | SILHOUETTE MALAR IMPLANT | Spectrum Designs, Inc. | 1994-11-04 |
| K944166 | DORSAL COLUMELLA IMPLANT | Spectrum Designs, Inc. | 1994-11-04 |
| K942420 | IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT | King & Spalding | 1994-08-08 |
| K942421 | IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT | King & Spalding | 1994-08-08 |
| K934233 | ZARA ZONE IV MALAR IMPLANT MODIFICATION | Byron Medical | 1994-02-03 |
| K921582 | FLOWERS MEDIAL MALAR IMPLANT | Implantech Associates, Inc. | 1992-05-06 |
| K914016 | ZARA ZONE IV MALAR IMPLANT | Byron Medical | 1991-12-05 |
| K911515 | EXTENDED MALAR IMPLANT | Implantech Associates, Inc. | 1991-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M724CBSMSIZNS1 | Conform Binder Submalar® Sizers | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724CSMSIZNS1 | Combined Submalar Shell™ Sizers | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724BSMIISIZNS1 | Binder Submalar® II Sizer | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724CMASIZNS1 | Conform Mandibular Angle™ Sizers | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724CCSMSIZNS1 | Conform Midfacial Implant Sizers | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724BSMSIZNS1 | Binder Submalar® Sizer | IMPLANTECH ASSOCIATES, INC. | 2017-10-17 |
| M724CCSMXSNS1 | Conform™ Midfacial | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CBSMXLNS1 | Conform Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CCSMLNS1 | Conform™ Midfacial | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CCSMMNS1 | Conform™ Midfacial | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CCSMSNS1 | Conform™ Midfacial | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CCSMXLNS1 | Conform™ Midfacial | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CSMXLNS1 | Combined Submalar Shell™ | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CSMLNS1 | Combined Submalar Shell™ | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CSMMNS1 | Combined Submalar Shell™ | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CSMSNS1 | Combined Submalar Shell™ | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724ALILNS1 | Arnett Lefort Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CBSMSNS1 | Conform Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CBSMMNS1 | Conform Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724CBSMLNS1 | Conform Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMXLNS1 | Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMSNS1 | Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMMNS1 | Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMLNS1 | Binder Submalar® | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMIIXLNS1 | Binder Submalar® II | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMIISNS1 | Binder Submalar® II | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMIIMNS1 | Binder Submalar® II | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724BSMIILNS1 | Binder Submalar® II | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724ALISNS1 | Arnett Lefort Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M724ALIMNS1 | Arnett Lefort Implant | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |