510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980138Substantially Equivalent

Spectrum Designs Symmetrical Chin Implant

Spectrum Designs, Inc., Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980138 is the FDA 510(k) clearance record for SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT, a class II device, cleared for Spectrum Designs, Inc. on under FDA product code FWP (Prosthesis, Chin, Internal). FDA records list 18 510(k) clearances for Spectrum Designs, Inc., from to . As of , FDA records show no recalls naming K980138.

Clearance record

Decision date
Received
(78 days to decision)
Product code
FWP Prosthesis, Chin, Internal
Regulation
21 CFR 878.3550
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Spectrum Designs, Inc. 5921 C. Matthews St., Goleta CA
510(k) summary
Summary
Third party review
No

Clearances, product code FWP

Trailing 12 months
1 clearance under product code FWP in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260