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510(k) K150428

Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs by Integra Lifesciences Corp. — Product Code HAE

K150428 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs". The FDA issued a decision of Substantially Equivalent on April 16, 2015. The device falls under product code HAE (Rongeur, Manual), a Class II device regulated under 21 CFR 882.4840. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2015
Date Received
February 19, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
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)
  • K131184 — INTEGRA LICOX PTO2 MONITOR (August 30, 2013)
  • K092227 — JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS (February 17, 2010)
  • K092395 — OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM (November 19, 2009)
  • K081635 — INTEGRA MESHED BILAYER WOUND MATRIX (December 4, 2008)
  • K081401 — MAYFIELD MR/X-RAY SKULL CLAMP (October 8, 2008)

Other clearances for product code HAE

  • K260446 — Tontarra Punches and Rongeurs (September 15, 2026)
  • K242759 — Geister K-Rex rongeurs (June 6, 2025)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K230256 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (March 3, 2023)
  • K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur (October 7, 2022)
  • K210741 — KLS Martin Neuro Rongeurs (June 3, 2022)
  • K200768 — Rebellion, Phantom Multi-Bite Kerrison Rongeur (May 4, 2021)
  • K200383 — Wiggins Medical Surgical Instruments (July 21, 2020)
  • K200387 — Ace Medical Surgical Instruments (July 21, 2020)
  • K180949 — Steribite (November 8, 2018)

FDA data resources