FDA product code LZK: Implant, Malar
LZK is the FDA product code for implant, malar. It is a Class II device, regulated under 21 CFR 878.3550 and reviewed by the General and Plastic Surgery panel. FDA has cleared 40 510(k) submissions under LZK, from 19 different applicants. The average 510(k) review took 67 days (median 66). FDA has posted 4 recalls for LZK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Malar |
| Device class | Class II |
| Regulation | 21 CFR 878.3550 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LZK clearance
Top LZK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implantech Associates, Inc. | 11 | 2000-11-24 |
| Spectrum Designs, Inc. | 6 | 1998-03-03 |
| Byron Medical | 3 | 1994-02-03 |
| Surgical Technology Laboratories, Inc. | 2 | 1998-11-20 |
| Ceramed Corp. | 2 | 1996-03-20 |
14 more applicants have LZK clearances. See the full list in Caduvo.
Most recent LZK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021419 | Aesthetic and Reconstructive Technologies, Inc. | AART MALAR IMPLANT | 2002-07-02 | 60 |
| K002886 | Implantech Associates, Inc. | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | 2000-11-24 | 70 |
| K992240 | Pillar Surgical, Inc. | PILLAR MALAR IMPLANT | 1999-11-22 | 143 |
| K983756 | Surgical Technology Laboratories, Inc. | SURGIFORM ANATOMICAL MALAR | 1998-11-20 | 29 |
| K982763 | Seare Biomedical Corp. | SEARE BIOMEDICAL MALAR IMPLANTS | 1998-09-30 | 55 |
Recalls for LZK devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LZK?
LZK is the FDA product code for implant, malar. It is a Class II device, regulated under 21 CFR 878.3550 and reviewed by the General and Plastic Surgery panel.
What device class is LZK?
Class II, regulation 21 CFR 878.3550. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZK?
Across 40 cleared submissions the average was 67 days from receipt to decision (median 66).
Which companies have the most LZK clearances?
Implantech Associates, Inc. (11); Spectrum Designs, Inc. (6); Byron Medical (3); Surgical Technology Laboratories, Inc. (2); Ceramed Corp. (2).
Have LZK devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code LZK
- Run a recall and safety report across every LZK manufacturer
- Watch product code LZK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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