510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883294Substantially Equivalent

Synthetic Cast Tape

Carapace, Inc., Martinez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883294 is the FDA 510(k) clearance record for SYNTHETIC CAST TAPE, a class I device, cleared for Carapace, Inc. on under FDA product code LGF (Component, Cast). FDA records list 22 510(k) clearances for Carapace, Inc., from to . As of , FDA records show no recalls naming K883294.

Clearance record

Decision date
Received
(26 days to decision)
Product code
LGF Component, Cast
Regulation
21 CFR 888.5940
Device class
Class I
Review panel
Orthopedic
Applicant
Carapace, Inc. C/O Buckman Co., Inc., Martinez CA
Third party review
No

Clearances, product code LGF

Trailing 12 months

FDA records hold no clearances under product code LGF in the trailing twelve months.

FDA records show no clearances under product code LGF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LGF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260