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510(k) K013442

PASS SPINAL SYSTEM by Encore Orthopedics, Inc. — Product Code KWP

K013442 is an FDA 510(k) premarket notification submitted by Encore Orthopedics, Inc. for the device "PASS SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 15, 2002. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Encore Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2002
Date Received
October 17, 2001
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 Encore Orthopedics, Inc.

  • K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT (July 6, 2004)
  • K020114 — 3D KNEE (July 12, 2002)
  • K020741 — UNICONDYLAR KNEE (June 4, 2002)
  • K020236 — MODIFICATION TO PASS SPINAL SYSTEM (February 14, 2002)
  • K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP (February 11, 2002)
  • K013490 — CEMENTED CALCAR HIP SYSTEM (January 17, 2002)
  • K003324 — PLASMA SPRAYED SHOULDER (December 6, 2001)
  • K013431 — PASS SPINAL SYSTEM (November 15, 2001)
  • K013191 — PASS SPINAL SYSTEM (October 24, 2001)
  • K011856 — RADIOGRAPHIC MARKERS (August 22, 2001)

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