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510(k) K983685

BONE BAND by Chapel and Assoc. — Product Code LYT

K983685 is an FDA 510(k) premarket notification submitted by Chapel and Assoc. for the device "BONE BAND". The FDA issued a decision of Substantially Equivalent on December 4, 1998. The device falls under product code LYT (Fixation Accessory), a Class II device regulated under 21 CFR 888.3030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1998
Date Received
October 20, 1998
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 for product code LYT

  • K040363 — CERAMIC TIPPED SKULL PIN (April 12, 2004)
  • 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)
  • K902053 — K-CAP-I ORTHOPEDIC FIXATION WIRE CAP (September 14, 1990)
  • K883576 — HORIZON ORTHOPEDIC PIN PROTECTOR (September 30, 1988)
  • K831072 — JURGAN PIN BALL (June 8, 1983)

FDA data resources