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510(k) K040363

CERAMIC TIPPED SKULL PIN by The Jerome Group, Inc. — Product Code LYT

K040363 is an FDA 510(k) premarket notification submitted by The Jerome Group, Inc. for the device "CERAMIC TIPPED SKULL PIN". The FDA issued a decision of Substantially Equivalent on April 12, 2004. The device falls under product code LYT (Fixation Accessory), a Class II device regulated under 21 CFR 888.3030. The Jerome Group, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2004
Date Received
February 13, 2004
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 The Jerome Group, Inc.

  • K023959 — JEROME GLASS RING (February 21, 2003)

Other clearances for product code LYT

  • 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)
  • 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