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
K983685Substantially Equivalent

Bone Band

Chapel and Assoc., Denton TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983685 is the FDA 510(k) clearance record for BONE BAND, a class II device, cleared for Chapel and Assoc. on under FDA product code LYT (Fixation Accessory). FDA records list one 510(k) clearance for Chapel and Assoc. As of , FDA records show no recalls naming K983685.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LYT Fixation Accessory
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Chapel and Assoc. 1019 Ridgecrest Cir., Denton TX
510(k) summary
Summary
Third party review
No

Clearances, product code LYT

Trailing 12 months

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

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