FDA.reportPublic FDA data

Depth Gauge Tube for screw length

Primary DI
07290115935028
Brand
Depth Gauge Tube for screw length
Company
PREMIA SPINE LTD
Model
87725
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150380000
K170061000
K231844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150380000ProMIS Fixation SystemPremia Spine, Ltd.2015-07-17NKB
K170061000ProMIS™ Fixation SystemPremia Spine, Ltd.2017-02-02NKB
K231844000ProMIS™ Fixation SystemPremia Spine, Ltd.2023-07-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115935028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115935028072901159350287290115935028

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290115932508Tower Guide ST86261N2026-07-23
07290115935578PER Trial 60890602026-07-22
07290115935691PER Trial 50890972026-07-22
07290115935837MIS Tower Guide86261N2026-06-01
07290115935349TOPS 2 - 21 S889442026-07-09
07290115935356TOPS 2 - 21 M889432026-07-09
07290115935363TOPS 2 - 21 L889422026-07-09
07290115935370TOPS 2 - 30 S889472026-07-09
07290115935387TOPS 2 - 30 M889462026-07-09
07290115935394TOPS 2 - 30 L889452026-07-09
07290115935400TOPS 2 - 38 S889502026-07-09
07290115935417TOPS 2 - 38 M889492026-07-09
07290115935424TOPS 2 - 38 L889482026-07-09
07290115935783TOPS 2 Inserter888932026-07-09
07290115932492Tower ST886062026-06-01
07290115932751Alignment Gauge Medium862022026-06-01
07290115932898Cannulated Screwdriver External sleeve865132026-06-01
07290115934076Tower ST Long Window889742026-06-01
07290115935622Cannulated Screwdriver Inner Shaft Short882642026-06-01
07290115935639Cannulated Screwdriver Handle Assy Short882652026-06-01

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Primary DI, Brand, Company table
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