FDA.reportPublic FDA data

General Instruments

Primary DI
00840180502648
Brand
General Instruments
Company
ALPHATEC SPINE, INC.
Model
CI-10717
Device description
8mm Angled TLIF Osteotome
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840180502648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840180502648008401805026488401805026480840180502648

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable 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
Primary DIBrandCompanyProduct codePublished
G149TBSB7860TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7870TBS BASICSACME ENTERPRISE.GFI2026-05-22
G149TBSB7880TBS BASICSACME ENTERPRISE.GFI2026-05-22
10889981443764SpecialsSeaspine Orthopedics CorporationGFI2026-03-03
D9281051992HF0SINUS INSTRUMENT #2 HF D/EW.H. Holden, Inc.GFI2026-02-19
10889981441340SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441357SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441364SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
10889981441371SpecialsSeaspine Orthopedics CorporationGFI2026-01-30
03662663220873Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220880Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
03662663220897Breckenridge ACDF SystemHighridge Medical, LLCGFI2026-01-13
10889981440787SpecialsSeaspine Orthopedics CorporationGFI2026-01-07
03662663156783SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156790SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156806SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
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03662663156820SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
03662663156837SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCGFI2025-12-29
00757770703708Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770703715Bausch + LombBausch & Lomb IncorporatedGFI2025-12-12
00757770447046Bausch + LombBausch & Lomb IncorporatedGFI2025-12-11
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00810207783381Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGFI2025-11-24