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510(k) K152604

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set by Medtronic Sofamor Danek USA, Incorporated — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2016
Date Received
September 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Posterior Screw Augmentation
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

The device is intended to augment the fixation of screws in a posterior spinal system construct.

Other clearances by Medtronic Sofamor Danek USA, Incorporated

  • K150200 — CD HORIZON Growth Rod Conversion Set (February 25, 2015)

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  • K222789 — VADER® Pedicle System, G21 Cement (January 9, 2023)
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  • K222256 — BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (August 26, 2022)
  • K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw System (October 28, 2021)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)
  • K201362 — CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone (August 19, 2020)