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510(k) K081401

Device
MAYFIELD MR/X-RAY SKULL CLAMP
Applicant
INTEGRA LIFESCIENCES CORP.
510(k) number
K081401
Product code
HBL  
Decision
Substantially Equivalent (SESE)
Decision date
2008-10-08
Date received
2008-05-19
Regulation
882.4460
Classification name
Holder, Head, Neurosurgical (skull Clamp)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HELDER A SOUSA
Address
311 Enterprise Dr. Planisboro NJ US 08536 08536

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH2025-11-06
K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH2024-07-26
K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH2024-04-24
K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH2021-03-29
K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH2020-06-02
K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH2020-02-21
K191701Arcus Head Fixation FrameMri Interventions, Inc.2019-11-15
K191979DORO QR3 XTom Headholder SystemPro Med Instruments GmbH2019-10-22
K163322TZ SKULL PIN AdultTz Medical, Inc.2017-02-23
K142238MAYFIELD Skull ClampIntegra LifeSciences Corporation2014-11-24
K141950HFD100 ROCKER ARM ACCESSORYImris, Inc.2014-09-04
K122225STERILE RADIOLUCENT SKULL PINSBrainlab AG2013-04-26
K130389MAYFIELD INFINITY XR2 SKULL CLAMPIntegra LifeSciences Corporation2013-04-23
K120633MAYFIELD SKULL CLAMPIntegra LifeSciences Corporation2012-05-24
K113748IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)Imris, Inc.2012-03-23

Legacy Summary#

summary

FDA Review#

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