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510(k) K920116

PWB LUMBOSACRAL SPINE SYSTEM by Cross Medical Products, Inc. — Product Code KWP

K920116 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "PWB LUMBOSACRAL SPINE SYSTEM". The FDA issued a decision of SN on April 10, 1992. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 10, 1992
Date Received
January 13, 1992
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 Cross Medical Products, Inc.

  • K974749 — SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY A (March 13, 1998)
  • K973836 — SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SY (March 5, 1998)
  • K950709 — SYNERGY TI ANTERIOR SPINAL SYSTEM (October 25, 1995)
  • K940631 — CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM (July 13, 1995)
  • K924381 — PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS (May 18, 1993)
  • K895587 — CROSS MEDICAL PRODUCT PEDICLE AWL (January 4, 1990)

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