Product code HTR— General, Plastic Surgery

FDA has cleared 9 devices under product code HTR between 1976 and 1987, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19873 clearances
• 19812 clearances
• 19782 clearances
• 19771 clearance
• 19761 clearance

• Biodynamic Technologies, Inc.3 clearances
• Richard'S Medical Equip., Inc.1 clearance
• Orthopedic Equipment Co., Inc.1 clearance
• Howmedica Corp.1 clearance
• Dyonics, Inc.1 clearance
• Depuy, Inc.1 clearance
• Amsco Co.1 clearance

• K870329 — ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202Biodynamic Technologies, Inc.·1987-02-13
• K870333 — BIODYNAMICS SMALL JOINT BRUSH #1203Biodynamic Technologies, Inc.·1987-02-13
• K870349 — BIODYNAMICS FEMORAL CANAL BRUSH #1201Biodynamic Technologies, Inc.·1987-02-13
• K813093 — RICHARDS ACETABULAR BRUSHRichard'S Medical Equip., Inc.·1981-11-20
• K812506 — THE ARTHROFILEDyonics, Inc.·1981-09-24
• K780771 — MICRO RASPSAmsco Co.·1978-05-16
• K771016 — INTERMEDULLARY BRUSHHowmedica Corp.·1978-01-12
• K771745 — RASPS FOR SCRAPING BONEDepuy, Inc.·1977-09-28
• K760109 — PROSTHESIS, TOTAL HIP-RASPOrthopedic Equipment Co., Inc.·1976-07-20