FDA.reportPublic FDA data

Intervertebral Disc Preparation Instruments

Primary DI
00190376378695
Brand
Intervertebral Disc Preparation Instruments
Company
ALPHATEC SPINE, INC.
Model
256-01-310-05
Device description
LIF, OSTEOTOME, CURVED, MEDIAL UP, 5MM
Published
2021-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00190376378695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376378695001903763786951903763786950190376378695

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
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
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00190376633442Valence Robotic Navigation System525-1050-0952026-02-26
00190376633459Valence Robotic Navigation System525-1050-1252026-02-26
00190376633466Valence Robotic Navigation System525-1050-1502026-02-26
00190376633473Valence Robotic Navigation System525-10702026-02-26
00190376633480Valence Robotic Navigation System525-10902026-02-26
00190376633497Valence Robotic Navigation System525-10912026-02-26
00190376633503Valence Robotic Navigation System525-11002026-02-26
00190376633510Valence Robotic Navigation System525-11012026-02-26
00190376633527Valence Robotic Navigation System525-11102026-02-26
00190376633534Valence Robotic Navigation System525-10402026-02-26
00190376634340Valence Robotic Navigation System525-10412026-02-26
00190376643670Valence Robotic Navigation System525-10602026-02-26

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Primary DI, Brand, Company table
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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
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