FDA.reportPublic FDA data

GSO ACP1 Spinal System

Primary DI
M9935097160
Brand
GSO ACP1 Spinal System
Company
UNIFIED SPINE, LLC
Model
509716
Device description
Caliper - Measuring Device
Published
2018-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
M9935097160PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9975087931GSO GS1 Cannulated Screw System5087932015-08-31
M9935011250GSO GS1 Spinal System5011252016-07-08
M9935011251GSO GS1 Spinal System5011252015-08-03
M9935012120GSO GS1 Spinal System5012122016-09-15
M9935012121GSO GS1 Spinal System5012122015-08-03
M9935012130GSO GS1 Spinal System5012132016-09-15
M9935012140GSO GS1 Spinal System5012142016-09-15
M9935012141GSO GS1 Spinal System5012142015-08-03
M9935012150GSO GS1 Spinal System5012152016-09-15
M9935012151GSO GS1 Spinal System5012152015-08-03
M9935012160GSO GS1 Spinal System5012162016-09-15
M9935012161GSO GS1 Spinal System5012162015-08-03
M9935012170GSO GS1 Spinal System5012172016-09-15
M9935012171GSO GS1 Spinal System5012172015-08-06
M9935012180GSO GS1 Spinal System5012182016-09-15
M9935012181GSO GS1 Spinal System5012182015-08-06
M9935012190GSO GS1 Spinal System5012192016-09-15
M9935012191GSO GS1 Spinal System5012192015-08-06
M9935012200GSO GS1 Spinal System5012202016-09-15
M9935012201GSO GS1 Spinal System5012202015-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00840343724863GEN2SURGIX MEDICAL LLCKTZ2025-01-13
00841336107144Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336107151Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336107236Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336108868Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109575Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109582Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109674Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109681Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109933Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11
00841336109964Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCKTZ2024-12-11