Spectrum Designs Profile Malar Implant
FDA 510(k) K980139 · Spectrum Designs, Inc.
510(k) numberK980139
Submission
- Device name
- Spectrum Designs Profile Malar Implant
- Applicant
- Spectrum Designs, Inc.
Goleta, CA, US - Received
- January 15, 1998
- Decision date
- March 3, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
|---|---|---|
| K992522 | Spectrum Designs SpectragelMDA · Traditional | 10/26/1999SE |
| K982688 | Spectrum Designs Pre-Form Contour Silicone Carving BlockMIB · Traditional | 10/13/1998SE |
| K980463 | Spectrum Designs Curvilinear Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980462 | Spectrum Designs Anatomical Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980446 | Spectrum Designs Anterior Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980445 | Spectrum Designs Concave Back Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980444 | Spectrum Designs Bilateral Groove Chin ImplantFWP · Traditional | 05/06/1998SE |
| K980138 | Spectrum Designs Symmetrical Chin ImplantFWP · Traditional | 04/03/1998SE |
| K980461 | Spectrum Designs Cleft Chin ImplantFWP · Traditional | 03/04/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | 03/03/1998SE |
Questions and answers
When was Spectrum Designs Profile Malar Implant cleared by the FDA?
Spectrum Designs Profile Malar Implant (K980139) received a 510(k) decision of Substantially Equivalent on March 3, 1998, 47 days after the submission was received.
What is the product code of K980139?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.