FDA.reportPublic FDA data

General Instrument

Primary DI
00840180507568
Brand
General Instrument
Company
ALPHATEC SPINE, INC.
Model
CI-10918-11
Device description
Battalion, LLIF Implant Slide Assy, Untracked, Long, 22mm Wide
Published
2022-10-13
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
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840180507568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840180507568008401805075688401805075680840180507568

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft guideA device used to protect a graft during delivery to the site of implantation. The graft is inserted into the device, which allows introduction and manoeuvring into difficult sites [e.g., during delivery into the tibial and femoral tunnel during anterior cruciate ligament (ACL) reconstruction surgery]. It is typically tubular-shaped, made of sturdy materials (e.g., stainless steel, hard plastic) and comes in varying sizes. This is a single-use device.

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
Premarket exempt
true
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
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00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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