Spectrum Designs, Inc.
Medical device manufacturer in Carpinteria, CA.
18510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 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 |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | 03/03/1998SE |
| K980139 | Spectrum Designs Profile Malar ImplantLZK · Traditional | 03/03/1998SE |
| K970702 | Spectrum Designs SpectragelMDA · Traditional | 05/12/1997SE |
| K960038 | Spectrum Designs Silicone BlockMIB · Traditional | 03/13/1996SE |
| K944163 | Spectrum Disigns Pectoral ImplantMIC · Traditional | 11/07/1994SE |
| K944166 | Dorsal Columella ImplantLZK · Traditional | 11/04/1994SE |
| K944165 | Silhouette Malar ImplantLZK · Traditional | 11/04/1994SE |
| K944164 | Meniscus Chin ImplantLZK · Traditional | 11/04/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1265-2007 | Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140…Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants | 07/24/2007Terminated |
| Z-1264-2007 | Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and…Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal… | 07/24/2007Terminated |
| Z-1206-2007 | Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number…The product is being recalled because it was discovered the at least one unit in the lot contained a… | 06/15/2007Terminated |