Medial Malar Implant
FDA 510(k) K961080 · Rand Scientific Corp.
510(k) numberK961080
Submission
- Device name
- Medial Malar Implant
- Applicant
- Rand Scientific Corp.
Sacramento, CA, US - Received
- March 18, 1996
- Decision date
- April 19, 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 |
|---|---|---|
| K963856 | Rand Nasal PackingEMX · Traditional | 10/18/1996SE |
| K961081 | Spirit Ridge Silicone Carving BlockMIB · Traditional | 05/22/1996SE |
| K961057 | Duralastic Sheeting IIMIB · Traditional | 05/16/1996SE |
| K955777 | Pmma ClasicHPX · Traditional | 05/16/1996SE |
| K961124 | The NautilusFZE · Traditional | 04/19/1996SE |
| K961072 | Pec ImplantMIC · Traditional | 04/19/1996SE |
| K961071 | The Magnum Chin ImplantFWP · Traditional | 04/19/1996SE |
| K955366 | Trans-Aire Rigid Gas Permable Contact LensHQD · Traditional | 03/28/1996SE |
| K952165 | Trans-Aire Rigid Gas Permeable Contact LensHQD · Traditional | 06/30/1995SE |
Questions and answers
When was Medial Malar Implant cleared by the FDA?
Medial Malar Implant (K961080) received a 510(k) decision of Substantially Equivalent on April 19, 1996, 32 days after the submission was received.
What is the product code of K961080?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.