Silimed Malar Implant
FDA 510(k) K981835 · Silimed, LLC
510(k) numberK981835
Submission
- Device name
- Silimed Malar Implant
- Applicant
- Silimed, LLC
Crofton, MD, US - Received
- May 26, 1998
- Decision date
- July 9, 1998
- 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 |
| 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 |
| K973574 | Duralastic Anatomical Malar ImplantLZK · Traditional | Hanson Medical, Inc. | 10/24/1997SE |
More from Hanson Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042054 | Silimed Pectoral ImplantMIB · Traditional | 02/23/2005SE |
| K981852 | Silimed Tissue ExpanderLCJ · Traditional | 08/05/1998SE |
| K974479 | Silimed Vaginal StentKXP · Traditional | 08/05/1998SE |
| K981851 | Silimed Silicone Carving BlockMIB · Traditional | 07/09/1998SE |
| K981850 | Silimed Chin ImplantsFWP · Traditional | 07/09/1998SE |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | 06/26/1998SE |
| K980221 | Silimed Nasal RetainerLYA · Traditional | 04/02/1998SE |
| K974482 | Silimed Gluteal ImplantMIB · Traditional | 02/24/1998SE |
| K974480 | Silimed Calf ImplantMIB · Traditional | 02/24/1998SE |
Questions and answers
When was Silimed Malar Implant cleared by the FDA?
Silimed Malar Implant (K981835) received a 510(k) decision of Substantially Equivalent on July 9, 1998, 44 days after the submission was received.
What is the product code of K981835?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.