Product code HTS— Orthopedic

FDA has cleared 9 devices under product code HTS between 1977 and 1994, filed by 6 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.

• 19942 clearances
• 19881 clearance
• 19874 clearances
• 19841 clearance
• 19771 clearance

• Arthropedics, Inc.4 clearances
• Richard Wolf Medical Instruments Corp.1 clearance
• Medtech Industries, Inc.1 clearance
• Karlin Technology, Inc.1 clearance
• Associated Medical Products Co.1 clearance
• Acufex Microsurgical, Inc.1 clearance

• K930507 — CUSTOM ORTHOPAEDIC TRAYS (PACKS)Associated Medical Products Co.·1994-02-22
• K933921 — ACUFLEX DISPOSABLE KNIVESAcufex Microsurgical, Inc.·1994-01-26
• K882525 — SPINAL MICROKNIFEKarlin Technology, Inc.·1988-09-22
• K873711 — RETROGRADE KNIFE, DISPOSABLE #TM-1613Arthropedics, Inc.·1987-11-02
• K873713 — TRIANGULAR KNIFE, DISPOSABLE #TM-1611Arthropedics, Inc.·1987-11-02
• K873714 — BANANA KNIFE, DISPOSABLE #TM-1612Arthropedics, Inc.·1987-11-02
• K873712 — STANDARD KNIFE, DISPOSABLE #TM-1610Arthropedics, Inc.·1987-10-15
• K842820 — ARTHROSCOPY KNIVESMedtech Industries, Inc.·1984-08-14
• K771851 — ARTHROSCOPE OPERATIVE KNIFE SETRichard Wolf Medical Instruments Corp.·1977-10-27