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510(k) K140645

GIBRALT ROD-TO-ROD CROSS CONNECTORS by Exactech Sarasota — Product Code KWP

K140645 is an FDA 510(k) premarket notification submitted by Exactech Sarasota for the device "GIBRALT ROD-TO-ROD CROSS CONNECTORS". The FDA issued a decision of Substantially Equivalent on April 11, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Exactech Sarasota has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2014
Date Received
March 13, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Exactech Sarasota

  • K110547 — OPTERTRAK LOGIC PSC TIBIAL INSERT (April 14, 2011)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources