Product code HTP— Orthopedic

FDA has cleared 5 devices under product code HTP between 1984 and 1994, filed by 5 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.

• 19941 clearance
• 19871 clearance
• 19861 clearance
• 19842 clearances

• Warsaw Orthopedic, Inc.1 clearance
• Suncoast Medical Manufacturers, Inc.1 clearance
• Stainless Mfg., Inc.1 clearance
• Intermedics Orthopedics1 clearance
• Concept, Inc.1 clearance

• K931733 — INTERMEDICS ORTHOPEDICS REAMERSIntermedics Orthopedics·1994-01-26
• K870842 — SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASPWarsaw Orthopedic, Inc.·1987-05-27
• K862659 — CONCEPT ARTHROSCOPY RASPConcept, Inc.·1986-09-02
• K841981 — 4MM & 5MM FILEStainless Mfg., Inc.·1984-06-19
• K840492 — SUN-LITE BLUE SLITSuncoast Medical Manufacturers, Inc.·1984-05-09