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510(k) K220486

Kentrospine PSS Pedicle Screw System by Rivarp Medical Private Limited — Product Code NKB

K220486 is an FDA 510(k) premarket notification submitted by Rivarp Medical Private Limited for the device "Kentrospine PSS Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Jul 22, 2022. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 22, 2022
Date Received
Feb 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type
510(k)

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (Jun 17, 2026)
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FDA data resources