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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 Dec 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
Dec 4, 1998
Date Received
Oct 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 (Apr 12, 2004)
  • K980594 — OSTEONICS FX-CABLELOK GRIP COMPONENTS (May 5, 1998)
  • K914812 — K-CAP-E, STERILE (Jan 9, 1992)
  • K912762 — K-CAP-I, STERILE (Jul 18, 1991)
  • K902053 — K-CAP-I ORTHOPEDIC FIXATION WIRE CAP (Sep 14, 1990)
  • K902676 — MICROGUARD, ORTHOPEDIC PIN PROTECTORS (Sep 14, 1990)
  • K883576 — HORIZON ORTHOPEDIC PIN PROTECTOR (Sep 30, 1988)
  • K831072 — JURGAN PIN BALL (Jun 8, 1983)

FDA data resources