Product code HWB— Orthopedic

FDA has cleared 5 devices under product code HWB between 1978 and 1987, 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.

• 19873 clearances
• 19801 clearance
• 19781 clearance

• Warsaw Orthopedic, Inc.1 clearance
• The Anspach Effort, Inc.1 clearance
• Terray Manufacturing, Inc.1 clearance
• Richard'S Medical Equip., Inc.1 clearance
• Arthropedics, Inc.1 clearance

Malfunction

1,893

Total

1,893

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K873710 — MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350Arthropedics, Inc.·1987-11-02
• K870844 — SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTORWarsaw Orthopedic, Inc.·1987-03-13
• K870083 — FERRAY EXTRACTORTerray Manufacturing, Inc.·1987-02-26
• K801327 — THE EXTRACTOR I TMThe Anspach Effort, Inc.·1980-06-09
• K780300 — HIP PLATE REMOVAL INSTRUMENTRichard'S Medical Equip., Inc.·1978-02-28