FDA.reportPublic FDA data

GSO GS1 Spinal System

Primary DI
M9935081230
Brand
GSO GS1 Spinal System
Company
UNIFIED SPINE, LLC
Model
508123
Device description
Calipers
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KTZCaliper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9935081230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone calliperA hand-held manual surgical instrument consisting of two legs hinged at one end designed to measure various bone dimensions (e.g., diameter or length) required for orthopaedic procedures. It has an attached scale to indicate the measured units. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118413370
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9935042050GSO GS1 Spinal System5042052018-09-21
M9935042180GSO GS1 Spinal System5042182018-09-21
M9935042190GSO GS1 Spinal System5042192018-09-21
M9935071650GSO PCT Spinal System5071652018-09-21
M9935071760GSO PCT Spinal System5071762018-09-21
M9935071770GSO PCT Spinal System5071772018-09-21
M9935091200GSO ACP1 Anterior Cervical Plate System5091202016-09-14
M9935091220GSO ACP1 Anterior Cervical Plate System5091222016-09-14
M9935091240GSO ACP1 Anterior Cervical Plate System5091242016-09-14
M9935091260GSO ACP1 Anterior Cervical Plate System5091262016-09-14
M9935091280GSO ACP1 Anterior Cervical Plate System5091282016-09-14
M9935091300GSO ACP1 Anterior Cervical Plate System5091302016-09-15
M9935091320GSO ACP1 Anterior Cervical Plate System5091322016-09-14
M9935092340GSO ACP1 Anterior Cervical Plate System5092342016-09-15
M9935092370GSO ACP1 Anterior Cervical Plate System5092372016-09-15
M9935092400GSO ACP1 Anterior Cervical Plate System5092402016-09-15
M9935092430GSO ACP1 Anterior Cervical Plate System5092432016-09-15
M9935092460GSO ACP1 Anterior Cervical Plate System5092462016-09-15
M9935092490GSO ACP1 Anterior Cervical Plate System5092492016-09-15
M9935092520GSO ACP1 Anterior Cervical Plate System5092522016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840180545706General InstrumentsALPHATEC SPINE, INC.KTZ2026-05-15
00840180545713General InstrumentsALPHATEC SPINE, INC.KTZ2026-05-15
00840343727338GEN2SURGIX MEDICAL LLCKTZ2026-04-16
09348811099037INKAThe Trustee for KAISER FAMILY TRUSTKTZ2026-04-10
09348811099044INKAThe Trustee for KAISER FAMILY TRUSTKTZ2026-03-18
00840311245680Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.KTZ2026-03-18
G079C5080000100MIS Golden Isles Pedicle Screw System Intelivation, LLCKTZ2026-01-30
00840180545287General InstrumentsALPHATEC SPINE, INC.KTZ2026-01-29
00190376680408ProximityALPHATEC SPINE, INC.KTZ2025-12-19
03662663244701Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
03662663244800Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
00887868457180Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
00888480500834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663131957Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663194020PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663194037PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663109925InViZia Anterior Cervical Plate SystemHighridge Medical, LLCKTZ2025-11-12
03662663126137Vital Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-07
00763000684112N/AMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-09-08
00194613115111MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-08-01
00190376585628InvictusALPHATEC SPINE, INC.KTZ2025-05-01
04719886908275USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KTZ2025-04-30
00194613050023MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00194613081515MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00763000864675n/aMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-03-11
09421028119290Kinematic Alignment Caliper – S+NENZTEC LIMITEDKTZ2025-01-24
00840306823749Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306823756Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306823831Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306821509Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-16