HTR · Class I · 21 CFR 878.4800

FDA Product Code HTR: Rasp

Leading manufacturers include Biodynamic Technologies, Inc., Orthopedic Equipment Co., Inc. and Howmedica Corp..

9
Total
9
Cleared
40d
Avg days
1976
Since

FDA 510(k) Cleared Rasp Devices (Product Code HTR)

9 devices
1–9 of 9
Cleared Feb 13, 1987
ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
K870329
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
BIODYNAMICS SMALL JOINT BRUSH #1203
K870333
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Feb 13, 1987
BIODYNAMICS FEMORAL CANAL BRUSH #1201
K870349
Biodynamic Technologies, Inc.
General & Plastic Surgery · 16d
Cleared Nov 20, 1981
RICHARDS ACETABULAR BRUSH
K813093
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 18d
Cleared Sep 24, 1981
THE ARTHROFILE
K812506
Dyonics, Inc.
General & Plastic Surgery · 23d
Cleared May 16, 1978
MICRO RASPS
K780771
Amsco Co.
General & Plastic Surgery · 11d
Cleared Jan 12, 1978
INTERMEDULLARY BRUSH
K771016
Howmedica Corp.
General & Plastic Surgery · 220d
Cleared Sep 28, 1977
RASPS FOR SCRAPING BONE
K771745
Depuy, Inc.
General & Plastic Surgery · 13d
Cleared Jul 20, 1976
PROSTHESIS, TOTAL HIP-RASP
K760109
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 26d

About Product Code HTR - Regulatory Context