Product code LYT— Orthopedic

FDA has cleared 9 devices under product code LYT between 1983 and 2004, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20041 clearance
• 19982 clearances
• 19921 clearance
• 19911 clearance
• 19902 clearances
• 19881 clearance
• 19831 clearance

• Westcon Orthopedics, Inc.3 clearances
• The Jerome Group, Inc.1 clearance
• Osteonics Corp.1 clearance
• Micro-Aire Surgical Instruments, Inc.1 clearance
• Jurgan Development & Mfg., Ltd.1 clearance
• Horizon Medical, Inc.1 clearance
• Chapel and Assoc.1 clearance

• K040363 — CERAMIC TIPPED SKULL PINThe Jerome Group, Inc.·2004-04-12
• K983685 — BONE BANDChapel and Assoc.·1998-12-04
• K980594 — OSTEONICS FX-CABLELOK GRIP COMPONENTSOsteonics Corp.·1998-05-05
• K914812 — K-CAP-E, STERILEWestcon Orthopedics, Inc.·1992-01-09
• K912762 — K-CAP-I, STERILEWestcon Orthopedics, Inc.·1991-07-18
• K902053 — K-CAP-I ORTHOPEDIC FIXATION WIRE CAPWestcon Orthopedics, Inc.·1990-09-14
• K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, Inc.·1990-09-14
• K883576 — HORIZON ORTHOPEDIC PIN PROTECTORHorizon Medical, Inc.·1988-09-30
• K831072 — JURGAN PIN BALLJurgan Development & Mfg., Ltd.·1983-06-08