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510(k) K131802

EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM by Depuy Spine, A Johnson & Johnson Company — Product Code OSH

K131802 is an FDA 510(k) premarket notification submitted by Depuy Spine, A Johnson & Johnson Company for the device "EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 12, 2013. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. Depuy Spine, A Johnson & Johnson Company has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2013
Date Received
June 19, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

Other clearances by Depuy Spine, A Johnson & Johnson Company

  • K102249 — EXPEDIUM SPINE SYSTEM (December 16, 2010)
  • K071927 — MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (November 21, 2007)
  • K071495 — EXPEDIUM 4.5MM SPINE SYSTEM (June 29, 2007)

Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
  • K140276 — CD HORIZON SPINAL SYSTEM (March 13, 2014)
  • K132574 — PASS LP SPINAL SYSTEM (November 8, 2013)
  • K132303 — IMPLANET SPINE SYSTEM (October 10, 2013)
  • K132575 — PASS LP SPINAL SYSTEM (October 3, 2013)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K131784 — RANGE SPINAL SYSTEM (August 30, 2013)
  • K131321 — CD HORIZON SPINAL SYSTEM (June 5, 2013)
  • K124058 — CREO STABILIZATION SYSTEM (May 13, 2013)
  • K131030 — RANGE SPINAL SYSTEM (May 9, 2013)

FDA data resources