FDA.reportPublic FDA data

General Instruments

Primary DI
00840180503584
Brand
General Instruments
Company
ALPHATEC SPINE, INC.
Model
CI-10116-9M
Device description
9x12x14mm, 5-deg Pegasus Trials w/Thru Hole
Published
2021-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150913000INCITE ANCHORED CERVICAL INTERBODY DEVICEIncite Innovation2015-04-30OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840180503584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840180503584008401805035848401805035840840180503584

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Height9Millimeter
Length16Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10195860030421E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030551E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030568E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030575E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030582E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030599E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030605E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030612E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030674E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030704E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030728E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030742E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030766E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030780E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030803E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030810E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030827E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030834E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030841E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030858E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030889E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030896E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030919E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030926E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20
10195860030964E3D-C Interbody SystemEvolution Spine LLCOVE2026-02-20