510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K770898Substantially Equivalent

Fracture Cast Brace Kit, Plastic

Chase Mfg. Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770898 is the FDA 510(k) clearance record for FRACTURE CAST BRACE KIT, PLASTIC, a class I device, cleared for Chase Mfg. Co. on under FDA product code HSP (Splint, Traction). FDA records list 10 510(k) clearances for Chase Mfg. Co., from to . As of , FDA records show no recalls naming K770898.

Clearance record

Decision date
Received
(66 days to decision)
Product code
HSP Splint, Traction
Regulation
21 CFR 888.5890
Device class
Class I
Review panel
Orthopedic
Applicant
Chase Mfg. Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HSP

Trailing 12 months

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

FDA records show no clearances under product code HSP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HSP, 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