FDA.reportPublic FDA data

Skull Pins

Primary DI
00811331011364
Brand
Skull Pins
Company
Tz Medical, Inc.
Model
SP-001
Device description
Stainless Steel Skull Pin
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K163322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163322000TZ SKULL PIN AdultTz Medical, Inc.2017-02-23HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811331011364PrimaryGS10
00811331011357Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811331011364008113310113648113310113640811331011364
00811331011357008113310113578113310113570811331011357

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine immobilization head ring rodAn implantable, threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level. Commonly referred to as a pin, it is typically made of metal (e.g., stainless steel), may be ceramic-tipped, or made of non-ferromagnetic materials. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Regulatory Flags#

DUNS number
793149709
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811331013610Retractor DistractorDP-72-CDR2025-02-12
00811331013634Retractor DistractorDP-74-CDL2025-02-12
00811331011227EZ HolderCT-00102023-10-20
00811331011340ARC Adjustable Radial CuffRCB-00482023-11-15
00811331011487ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011500ARC Adjustable Radial CuffRCB-00472023-11-15
00811331011470ARC Adjustable Radial CuffRCB-00492023-11-15
00811331011333ARC Adjustable Radial CuffRCB-00472023-11-15
00811331013917H3R USB CableH3R-00252023-11-15
00811331013931H3R HolsterH3R-00272023-11-15
10811331010173Comfort BandCB-8514B2023-10-20
10811331010180Comfort BandCB-8517P2023-10-20
10811331010487TZ Medical Pressure Discs8880-042023-10-20
10811331013259TZ Medical Pressure Discs8880-032023-10-20
00811331010053TZ Medical Pressure Discs8880-022023-10-20
00811331011654TruBrite Adhesive Retractor LightARL-10102023-10-20
00811331011722TZ Medical Pressure Discs8880-012023-10-20
00811331011845TZ Medical Pressure Discs8880-062023-10-20
00811331013245TZ Medical Pressure Discs8880-022023-10-20
00811331011210EZ HolderCT-00102023-10-20

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Primary DI, Brand, Company table
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