FDA.reportPublic FDA data

Navigated Instrument System

Primary DI
00840019970631
Brand
Navigated Instrument System
Company
PRECISION SPINE, INC.
Model
76-CR-0700
Catalog number
76-CR-0700
Device description
S-COMP Reform® POCT Polyaxial Driver
Published
2024-01-04
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
NKGPosterior Cervical Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231229000S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.2023-05-25OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019970631PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019970631008400199706318400199706310840019970631

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934909Reform Ti39-TD-555539-TD-55552019-10-04
00840019934916Reform Ti39-TD-556039-TD-55602019-10-04
00840019934923Reform Ti39-TD-652539-TD-65252019-10-04
00840019934930Reform Ti39-TD-653039-TD-65302019-10-04
00840019934947Reform Ti39-TD-653539-TD-65352019-10-04
00840019934954Reform Ti39-TD-654039-TD-65402019-10-04
00840019934961Reform Ti39-TD-654539-TD-65452019-10-04
00840019934978Reform Ti39-TD-655039-TD-65502019-10-04
00840019934985Reform Ti39-TD-655539-TD-65552019-10-04
00840019934992Reform Ti39-TD-656039-TD-65602019-10-04
00840019935005Reform Ti39-TD-753039-TD-75302019-10-04
00840019935012Reform Ti39-TD-753539-TD-75352019-10-04
00840019935029Reform Ti39-TD-754039-TD-75402019-10-04
00840019935036Reform Ti39-TD-754539-TD-75452019-10-04
00840019935043Reform Ti39-TD-755039-TD-75502019-10-04
00840019935050Reform Ti39-TD-755539-TD-75552019-10-04
00840019935067Reform Ti39-TD-756039-TD-75602019-10-04
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992521INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00763000992552INFINITY OCT SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-09-26
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
00848486001414VIZADISCMAKO SURGICAL CORP.OLO2016-09-24
04546540371508OASYSStryker CorporationNKG2015-09-14
04546540371553OASYSStryker CorporationNKG2015-09-14
04546540371560OASYSStryker CorporationNKG2015-09-14
04546540371577OASYSStryker CorporationNKG2015-09-14
04546540371584OASYSStryker CorporationNKG2015-09-14
04546540371591OASYSStryker CorporationNKG2015-09-14
04546540371607OASYSStryker CorporationNKG2015-09-14
04546540371614OASYSStryker CorporationNKG2015-09-14
04546540371621OASYSStryker CorporationNKG2015-09-14
04546540371638OASYSStryker CorporationNKG2015-09-14
04546540371645OASYSStryker CorporationNKG2015-09-14
04546540371652OASYSStryker CorporationNKG2015-09-14
04546540371669OASYSStryker CorporationNKG2015-09-14
04546540371676OASYSStryker CorporationNKG2015-09-14
04546540371683OASYSStryker CorporationNKG2015-09-14
04546540371690OASYSStryker CorporationNKG2015-09-14
04546540371706OASYSStryker CorporationNKG2015-09-14
04546540371713OASYSStryker CorporationNKG2015-09-14
04546540371720OASYSStryker CorporationNKG2015-09-14
04546540371737OASYSStryker CorporationNKG2015-09-14