Home / 510(k) Clearances / K132303

510(k) K132303

IMPLANET SPINE SYSTEM by Implanet, S.A. — Product Code OSH

K132303 is an FDA 510(k) premarket notification submitted by Implanet, S.A. for the device "IMPLANET SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 10, 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. Implanet, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2013
Date Received
July 24, 2013
Clearance Type
Traditional
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 Implanet, S.A.

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K252437 — JAZZ Spinal System (August 28, 2025)
  • K240392 — JAZZ Spinal System (May 6, 2024)
  • K230026 — SQUALE (March 28, 2023)
  • K192084 — Madison Total Knee System (October 22, 2019)
  • K191217 — JAZZ PF (August 2, 2019)
  • K182771 — ISS-JAZZ Screw System and JAZZ CAP SP (March 12, 2019)
  • K171881 — JAZZ Passer Band (August 8, 2017)
  • K170730 — JAZZ System, including JAZZ Band (June 9, 2017)
  • K162764 — JAZZ FRAME SYSTEM (January 19, 2017)

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)
  • K132575 — PASS LP SPINAL SYSTEM (October 3, 2013)
  • K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (September 12, 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