Hall Osteon

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K833187 ↗

FDA Product Code

GET

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Surgical Light

  Class II

  FDA 510(k) K823360 Active Cleared 3 Dec 1982

• Amsco Polaris Sl

  Class II

  FDA 510(k) K854922 Active Cleared 24 Jan 1986

• Sternum Saw

  Class I

  FDA 510(k) K801737 Active Cleared 20 Aug 1980

• Biological/Chemical Indicator

  Class II

  FDA 510(k) K772135 Active Cleared 8 Dec 1977

• Sternum Saw Blade

  Class I

  FDA 510(k) K802838 Active Cleared 11 Dec 1980

• Eagle 3000 Sds

  Class II

  FDA 510(k) K912471 Active Cleared 26 Jun 1992

See all devices from Amsco Co. →