Spectrum Designs, Inc.
Goleta, CA, US
Spectrum Designs, Inc. appears in FDA device records in Goleta, CA. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Spectrum Designs, Inc. between 1994 and 1999. The busiest year on record is 1998, with 11. The most recent is 1999, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 11 |
| 1999 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992522 | SPECTRUM DESIGNS SPECTRAGEL | MDA | Substantially Equivalent | |
| K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | MIB | Substantially Equivalent | |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | FWP | Substantially Equivalent | |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | LZK | Substantially Equivalent | |
| K980140 | SPECTRUM DESIGNS MEDIAL MALAR IMPLANT | LZK | Substantially Equivalent | |
| K980139 | SPECTRUM DESIGNS PROFILE MALAR IMPLANT | LZK | Substantially Equivalent | |
| K970702 | SPECTRUM DESIGNS SPECTRAGEL | MDA | Substantially Equivalent | |
| K960038 | SPECTRUM DESIGNS SILICONE BLOCK | MIB | Substantially Equivalent | |
| K944163 | SPECTRUM DISIGNS PECTORAL IMPLANT | MIC | Substantially Equivalent | |
| K944166 | DORSAL COLUMELLA IMPLANT | LZK | Substantially Equivalent | |
| K944165 | SILHOUETTE MALAR IMPLANT | LZK | Substantially Equivalent | |
| K944164 | MENISCUS CHIN IMPLANT | LZK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1265-2007 | Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Lot # 31140; Serial Numbers BAHO45 through BAH144 | Mispackaging/Mislabeing: a portion of the lot may be labeled as containing nasal implants | Terminated | ||
| Z-1264-2007 | Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S and Lot #31053; Serial Numbers: BAG612 ,BAG6I3, BAG6I4, BAG652, BAG654 and BAG655 | Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant. | Terminated | ||
| Z-1206-2007 | Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S. | The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain