Surgiform Anatomical Malar
FDA 510(k) K964443 · Surgical Technology Laboratories, Inc.
510(k) numberK964443
Submission
- Device name
- Surgiform Anatomical Malar
- Applicant
- Surgical Technology Laboratories, Inc.
Cleveland, OH, US - Received
- November 6, 1996
- Decision date
- December 20, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LZK – Implant, Malar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code LZK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021419 | Aart Malar ImplantLZK · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | Implantech Associates, Inc. | 11/24/2000SE |
| K992240 | Pillar Malar ImplantLZK · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | Silimed, LLC | 07/09/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980139 | Spectrum Designs Profile Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K973502 | Implantech Conform Binder Submalar ImplantLZK · Traditional | Implantech Associates, Inc. | 11/07/1997SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170582 | Saf-T-Vac Smoke and Fluid EvacuatorGEI · Traditional | 04/14/2017SE |
| K021889 | Surgiform Augmentation Material (S.F.A.M.)KKY · Traditional | 10/16/2002SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | 11/20/1998SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | 11/20/1998SE |
| K983754 | Standard ChinFWP · Special | 11/20/1998SE |
| K840835 | Straith Drain InserterFZX · Traditional | 04/23/1984SE |
| K831078 | Straith Oral AirwayCAE · Traditional | 06/24/1983SE |
| K801074 | Straith Nasal ImplantFZE · Traditional | 06/17/1980SE |
| K801072 | Straith Nasal SplintFYI · Traditional | 06/17/1980SE |
| K801075 | Straith Chisel ForcepsGEN · Traditional | 05/20/1980SE |
Questions and answers
When was Surgiform Anatomical Malar cleared by the FDA?
Surgiform Anatomical Malar (K964443) received a 510(k) decision of Substantially Equivalent on December 20, 1996, 44 days after the submission was received.
What is the product code of K964443?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.