Medical Device Manufacturer · US , Goleta , CA

Spectrum Designs, Inc.

18 submissions · 18 cleared · Since 1994
18
Total
18
Cleared
0
Denied

Spectrum Designs, Inc. — FDA 510(k) Submissions

Spectrum Designs, Inc. has submitted 18 FDA 510(k) premarket notifications since 1994, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Chin, Internal, Implant, Malar, Elastomer, Silicone, For Scar Management, Elastomer, Silicone Block, Implant, Muscle, Pectoralis . Use the specialty filter in the sidebar to narrow results.

18 devices
1–12 of 18
SPECTRUM DESIGNS SPECTRAGEL
K992522 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Oct 1999 90d
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K982688 · MIB Elastomer, Silicone Block · General & Plastic Surgery
Oct 1998 71d
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K980444 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
May 1998 90d
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K980445 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
May 1998 90d
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K980446 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
May 1998 90d
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
K980462 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
May 1998 90d
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K980463 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
May 1998 90d
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K980138 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Apr 1998 78d
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K980461 · FWP Prosthesis, Chin, Internal · General & Plastic Surgery
Mar 1998 27d
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
K980139 · LZK Implant, Malar · General & Plastic Surgery
Mar 1998 47d
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
K980140 · LZK Implant, Malar · General & Plastic Surgery
Mar 1998 47d
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
K980141 · LZK Implant, Malar · General & Plastic Surgery
Mar 1998 47d
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