Data / Medical devices / Implant, Malar
Implant, Malar (LZK): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Implant, Malar (product code LZK, Class 2, 21 CFR 878.3550). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 40 510(k) clearances under this code, the latest on July 2, 2002, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LZK
- Device class
- 2
- Regulation
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Implant, Malar
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Implantech Associates, Inc. | Ventura, CA, United States | Manufacturer | 17 | November 24, 2000 | 0 | 0 | 0 | api.fda.gov |
| Dsaart, LLC | Carson City, NV, United States | Manufacturer | 1 | July 2, 2002 | 0 | 1 | 0 | api.fda.gov |
| Hanson Medical, Inc. | Paso Robles, CA, United States | Manufacturer | 1 | October 24, 1997 | 0 | 0 | 0 | api.fda.gov |
| Surgical Technology Laboratories Inc. | Lugoff, SC, United States | Manufacturer | 1 | November 20, 1998 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.