Spectrum Designs Anterior Chin Implant
FDA 510(k) K980446 · Spectrum Designs, Inc.
510(k) numberK980446
Submission
- Device name
- Spectrum Designs Anterior Chin Implant
- Applicant
- Spectrum Designs, Inc.
Goleta, CA, US - Received
- February 5, 1998
- Decision date
- May 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | Implantech Associates, Inc. | 07/10/2014SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | Howmedica Osteonics Corp. | 11/01/2012SE |
More from Howmedica Osteonics Corp.
| 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 |
| 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 |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | 03/03/1998SE |
Questions and answers
When was Spectrum Designs Anterior Chin Implant cleared by the FDA?
Spectrum Designs Anterior Chin Implant (K980446) received a 510(k) decision of Substantially Equivalent on May 6, 1998, 90 days after the submission was received.
What is the product code of K980446?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.