150 Driver Reamer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812437 ↗

FDA Product Code

GEY

Device Class

Class I

Regulation

21 CFR Part 878.4820

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Power Pack

  Class I

  FDA 510(k) K800314 Active Cleared 19 Mar 1980

• 450/800 Drill

  Class II

  FDA 510(k) K812436 Active Cleared 2 Nov 1981

• Sagittal Saw

  Class I

  FDA 510(k) K812438 Active Cleared 2 Nov 1981

• 150 Driver/Reamer

  Class I

  FDA 510(k) K800312 Active Cleared 22 Feb 1980

• 450 Drill/800 Drill

  Class I

  FDA 510(k) K800311 Active Cleared 22 Feb 1980

• Dual Mpc Charger

  Class I

  FDA 510(k) K800315 Active Cleared 19 Mar 1980

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