FDA.reportPublic FDA data

MAYFIELD®

Primary DI
10381780354802
Brand
MAYFIELD®
Company
INTEGRA LIFESCIENCES CORPORATION
Model
S419A1208
Device description
MAYFIELD® Infinity Skull Clamp System Reduced Load 18-lb Torque Screw
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBLHOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051440000MAYFIELD INFINITY SKULL CLAMPIntegra Lifesciences Corp.2005-09-20HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780354802PrimaryGS10
M268S419A12081SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178035480210381780354802

GMDN Terms#

Term, Definition table
TermDefinition
Skull clampA U-shaped surgical device intended to hold the head and neck in a particular fixed position during surgical procedures. It is connected to the skull with screws or pins (not included), typically on each side of the forehead, whilst the other end is fixed to an operating table or chair. Commonly known as a Mayfield skull clamp, it is made of metal materials (non-radiolucent) and may have adjustable joints (either incorporated or separate) for positioning/stabilization; it is not intended for applying traction forces to the cervical spine. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
963856096
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780253716MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256113MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256120MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256137MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256144MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256151MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256175MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256182MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256199MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256205MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256212MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256229MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256236MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256243MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256250MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256267MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256274MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256281MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780256687MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-08-02
10381780025757MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025764MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025771MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025788MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025795MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780025818MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253334MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253341MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253358MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253365MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26
10381780253372MAYFIELD®INTEGRA LIFESCIENCES CORPORATIONHBL2016-07-26