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510(k) K914812

K-CAP-E, STERILE by Westcon Orthopedics, Inc. — Product Code LYT

K914812 is an FDA 510(k) premarket notification submitted by Westcon Orthopedics, Inc. for the device "K-CAP-E, STERILE". The FDA issued a decision of Substantially Equivalent on January 9, 1992. 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
January 9, 1992
Date Received
October 25, 1991
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.

  • K912762 — K-CAP-I, STERILE (July 18, 1991)
  • K902053 — K-CAP-I ORTHOPEDIC FIXATION WIRE CAP (September 14, 1990)
  • 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)
  • K912762 — K-CAP-I, STERILE (July 18, 1991)
  • K902053 — K-CAP-I ORTHOPEDIC FIXATION WIRE CAP (September 14, 1990)
  • 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