Company ยท US
Spectrum Designs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1999. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 26, 1999 | K992522 | SPECTRUM DESIGNS SPECTRAGEL Spectrum Designs, Inc. | MDA |
| Oct 13, 1998 | K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK Spectrum Designs, Inc. | MIB |
| May 6, 1998 | K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| May 6, 1998 | K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| May 6, 1998 | K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| May 6, 1998 | K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| May 6, 1998 | K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| Apr 3, 1998 | K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| Mar 4, 1998 | K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT Spectrum Designs, Inc. | FWP |
| Mar 3, 1998 | K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT Spectrum Designs, Inc. | LZK |
| Mar 3, 1998 | K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT Spectrum Designs, Inc. | LZK |
| Mar 3, 1998 | K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT Spectrum Designs, Inc. | LZK |
| May 12, 1997 | K970702 | SPECTRUM DESIGNS SPECTRAGEL Spectrum Designs, Inc. | MDA |
| Mar 13, 1996 | K960038 | SPECTRUM DESIGNS SILICONE BLOCK Spectrum Designs, Inc. | MIB |
| Nov 7, 1994 | K944163 | SPECTRUM DISIGNS PECTORAL IMPLANT Spectrum Designs, Inc. | MIC |
| Nov 4, 1994 | K944166 | DORSAL COLUMELLA IMPLANT Spectrum Designs, Inc. | LZK |
| Nov 4, 1994 | K944165 | SILHOUETTE MALAR IMPLANT Spectrum Designs, Inc. | LZK |
| Nov 4, 1994 | K944164 | MENISCUS CHIN IMPLANT Spectrum Designs, Inc. | LZK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2007 | Spectrum Designs Inc Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S. Terminated |
LZK | K944165 |
| Jul 24, 2007 | Spectrum Designs Inc Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144 Terminated |
LZK | K944164 |
| Jul 24, 2007 | Spectrum Designs Inc Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655 Terminated |
LZK | K944166 |