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510(k) K934007

SOFAMOR ORFIL SPINE FIXATION SYSTEM by Sofamor Co. — Product Code KWP

K934007 is an FDA 510(k) premarket notification submitted by Sofamor Co. for the device "SOFAMOR ORFIL SPINE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 1994. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Sofamor Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1994
Date Received
August 18, 1993
Clearance Type
Traditional
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 Sofamor Co.

  • K940744 — SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION (January 30, 1996)
  • K945022 — APOFIX CERVICAL SPINE FIXATION (May 15, 1995)
  • K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY (December 7, 1987)
  • K843687 — ROD FOR RACHIS SURGERY (January 10, 1985)

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)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — 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