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510(k) K980594

OSTEONICS FX-CABLELOK GRIP COMPONENTS by Osteonics Corp. — Product Code LYT

K980594 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEONICS FX-CABLELOK GRIP COMPONENTS". The FDA issued a decision of Substantially Equivalent on May 5, 1998. The device falls under product code LYT (Fixation Accessory), a Class II device regulated under 21 CFR 888.3030. Osteonics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1998
Date Received
February 17, 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 by Osteonics Corp.

  • K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY (April 6, 2000)
  • K980070 — OSTEONICS HA-COATED DEVICES (July 23, 1999)
  • K984375 — OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY (April 30, 1999)
  • K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM (March 25, 1999)
  • K984585 — OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (February 24, 1999)
  • K990203 — OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (February 18, 1999)
  • K990158 — OSTEONICS COMBINATION SCREW RING/BLOCKER (February 1, 1999)
  • K984302 — OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (December 18, 1998)
  • K984353 — OSTEO 9MM IC TIBIAL NAIL (December 16, 1998)
  • K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM (December 16, 1998)

Other clearances for product code LYT

  • K040363 — CERAMIC TIPPED SKULL PIN (April 12, 2004)
  • K983685 — BONE BAND (December 4, 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