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510(k) K022623

5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM) by Depuyacromed — Product Code KWP

K022623 is an FDA 510(k) premarket notification submitted by Depuyacromed for the device "5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)". The FDA issued a decision of Substantially Equivalent on August 27, 2002. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Depuyacromed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2002
Date Received
August 7, 2002
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 Depuyacromed

  • K040197 — EAGLE ANTERIOR CERVIAL PLATE SYSTEM (April 2, 2004)
  • K031635 — DEPUY ACROMED VBR SYSTEM (June 23, 2003)
  • K030833 — DEPUY ACROMED VBR SYSTEM (April 10, 2003)
  • K030383 — MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS (February 26, 2003)
  • K030249 — SURGICAL TITANIUM MESH SYSTEM (February 14, 2003)
  • K030103 — SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS (February 5, 2003)
  • K023835 — DEVEX MESH SYSTEM (January 29, 2003)
  • K024348 — MONARCH SPINE SYSTEM (January 28, 2003)
  • K023804 — MOSS MIAMI SPINAL SYSTEM PIN NUT (January 23, 2003)
  • K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM (December 11, 2002)

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