Home / 510(k) Clearances / K071138

510(k) K071138

CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM by Prosurg, Inc. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2007
Date Received
March 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

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  • K120766 — ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) (September 11, 2012)
  • K072528 — ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & AC (December 28, 2007)
  • K070737 — XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES (July 25, 2007)
  • K070846 — MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM (July 2, 2007)
  • K060326 — LASERTX - DIODE LASER & DELIVERY SYSTEM (April 5, 2006)
  • K050488 — TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES (April 1, 2005)
  • K042780 — NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (February 3, 2005)

Other clearances for product code GXR

  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221606 — Absorbable Cranial Flap Fixation System (November 21, 2023)
  • K192310 — Flap Fixator, Burr Hole Cover (June 3, 2020)
  • K192162 — NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Pl (March 13, 2020)
  • K181539 — OSSDSIGN Cranioplug (October 12, 2018)
  • K181382 — GuardianTM Burr Hole Cover System (July 20, 2018)
  • K160739 — Cranial COVER (June 12, 2016)
  • K152342 — Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover (June 9, 2016)
  • K140309 — CRANIOPLUG (October 3, 2014)
  • K141368 — NEUROPACE BURR HOLE COVER (July 11, 2014)