FDA.reportPublic FDA data

Feeler Gauge - Thick

Primary DI
07290115934847
Brand
Feeler Gauge - Thick
Company
PREMIA SPINE LTD
Model
87353
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182598000VersaLink™ Fixation SystemPremia Spine, Ltd.2018-11-13NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934847072901159348477290115934847

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

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
07290014064973ProMIS™ Fixation System862412015-12-04
07290014064980ProMIS™ Fixation System862422015-12-04
07290014064997ProMIS™ Fixation System862432015-12-04
07290014080003ProMIS™ Fixation System862442015-12-04
07290014080010ProMIS™ Fixation System862452015-12-04
07290014080027ProMIS™ Fixation System862462015-12-04
07290014080034ProMIS™ Fixation System862472015-12-04
07290014080263ProMIS™ Fixation System864012016-02-04
07290014080270ProMIS™ Fixation System864022016-02-04
07290014080287ProMIS™ Fixation System864032016-02-04
07290014080294ProMIS™ Fixation System864042016-02-04
07290014080324ProMIS™ Fixation System867942016-03-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
04546540147257XIA IIStryker CorporationNKB2014-12-08
04546540147769XIA IIStryker CorporationNKB2014-12-08
04546540147806XIA IIStryker CorporationNKB2014-12-08
04546540147905XIA IIStryker CorporationNKB2014-12-08
04546540147912XIA IStryker CorporationNKB2014-12-08
04546540147929XIA IStryker CorporationNKB2014-12-08
04546540147936XIA IStryker CorporationNKB2014-12-08
04546540147974XIA IStryker CorporationNKB2014-12-08
04546540147981XIA IStryker CorporationNKB2014-12-08
04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
04546540148025XIA IIStryker CorporationNKB2014-12-08
04546540148735XIA IIStryker CorporationNKB2014-12-08
04546540148742XIA IIStryker CorporationNKB2014-12-08
04546540148759XIA IIStryker CorporationNKB2014-12-08