Home / 510(k) Clearances / K092395

510(k) K092395

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM by Integra Lifesciences Corp. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2009
Date Received
August 5, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Integra Lifesciences Corp.

  • K183581 — Codman Disposable Perforators (January 20, 2019)
  • K183406 — CereLink ICP Monitor, CereLink ICP Extension Cable (January 11, 2019)
  • K182265 — CodMan Certas Plus Programmable Valve (November 20, 2018)
  • K181902 — Codman Certas Plus Electronic Tool Kit (October 25, 2018)
  • K150682 — CUSA Excel+ (December 18, 2015)
  • K150428 — Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) K (April 16, 2015)
  • K131184 — INTEGRA LICOX PTO2 MONITOR (August 30, 2013)
  • K092227 — JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (February 17, 2010)
  • K081635 — INTEGRA MESHED BILAYER WOUND MATRIX (December 4, 2008)
  • K081401 — MAYFIELD MR/X-RAY SKULL CLAMP (October 8, 2008)

Other clearances for product code JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)