Home / 510(k) Clearances / K902053

510(k) K902053

K-CAP-I ORTHOPEDIC FIXATION WIRE CAP by Westcon Orthopedics, Inc. — Product Code LYT

K902053 is an FDA 510(k) premarket notification submitted by Westcon Orthopedics, Inc. for the device "K-CAP-I ORTHOPEDIC FIXATION WIRE CAP". The FDA issued a decision of Substantially Equivalent on September 14, 1990. The device falls under product code LYT (Fixation Accessory), a Class II device regulated under 21 CFR 888.3030. Westcon Orthopedics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1990
Date Received
May 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixation Accessory
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Westcon Orthopedics, Inc.

  • K914812 — K-CAP-E, STERILE (January 9, 1992)
  • K912762 — K-CAP-I, STERILE (July 18, 1991)
  • K901525 — K-CAPE ORTHOPEDIC WIRES AND PINS (April 23, 1990)

Other clearances for product code LYT

  • K040363 — CERAMIC TIPPED SKULL PIN (April 12, 2004)
  • K983685 — BONE BAND (December 4, 1998)
  • K980594 — OSTEONICS FX-CABLELOK GRIP COMPONENTS (May 5, 1998)
  • K914812 — K-CAP-E, STERILE (January 9, 1992)
  • K912762 — K-CAP-I, STERILE (July 18, 1991)
  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (September 14, 1990)
  • K883576 — HORIZON ORTHOPEDIC PIN PROTECTOR (September 30, 1988)
  • K831072 — JURGAN PIN BALL (June 8, 1983)

FDA data resources