Osteotomy Instruments

GUDID 00190376513058

LIF Osteotome, Curved 8mm

ALPHATEC SPINE, INC.

Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome
Primary Device ID00190376513058
NIH Device Record Keyb81c0e1c-7a55-4e26-83b5-c0b8043622fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotomy Instruments
Version Model Number152-01-001-08
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376513058 [Primary]

FDA Product Code

GFIOSTEOTOME, MANUAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


[00190376513058]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-12

On-Brand Devices [Osteotomy Instruments]

00190376538549Lateral Corpectomy Osteotomy Instruments Alpha System
00190376538532Posterior Corpectomy Osteotomy Instruments Alpha System
00190376517148ADJUSTABLE VB SPOON RETRACTOR, 30mm
00190376517131ADJUSTABLE VB SPOON RETRACTOR, 20mm
00190376517124ADJUSTABLE VB SPOON RETRACTOR, 15mm
00190376516455CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 10
00190376516448CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 9
00190376516431CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 8
00190376516424CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 7
00190376516417CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 5
00190376516400CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 4
00190376516394CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 3
00190376516387CUP CURETTE, STRAIGHT, UP ANGLED, SIZE 2
00190376515953LIF Osteotome, Curved 40mm
00190376515939LIF Osteotome, Curved 38mm
00190376515915LIF Osteotome, Curved 36mm
00190376515892LIF Osteotome, Curved 34mm
00190376515878LIF Osteotome, Curved 32mm
00190376515854LIF Osteotome, Curved 6mm
00190376515830LIF Osteotome, Straight 40mm
00190376515816LIF Osteotome, Straight 38mm
00190376515793LIF Osteotome, Straight 36mm
00190376515779LIF Osteotome, Straight 34mm
00190376515755LIF Osteotome, Straight 32mm
00190376515731LIF Osteotome, Straight 6mm
00190376515717Osteotome, Curved 40mm
00190376515694Osteotome, Curved 38mm
00190376515670Osteotome, Curved 36mm
00190376515656Osteotome, Curved 34mm
00190376515632Osteotome, Curved 32mm
00190376515618Osteotome, Curved 6mm
00190376515595Osteotome, Straight 40mm
00190376515571Osteotome, Straight 38mm
00190376515557Osteotome, Straight 36mm
00190376515533Osteotome, Straight 34mm
00190376515519Osteotome, Straight 32mm
00190376515496Osteotome, Straight 6mm
00190376514260Posterior Vertebral Body Punch, 30mm
00190376514253Posterior Vertebral Body Punch, 25mm
00190376514246Cup Curette, Straight, Up Angled, Size 06
00190376514239Right Angle Osteotome, 7mm
00190376513164LIF Osteotome, Curved 30mm
00190376513157LIF Osteotome, Curved 28mm
00190376513140LIF Osteotome, Curved 26mm
00190376513133LIF Osteotome, Curved 24mm
00190376513126LIF Osteotome, Curved 22mm
00190376513119LIF Osteotome, Curved 20mm
00190376513102LIF Osteotome, Curved 18mm
00190376513096LIF Osteotome, Curved 16mm
00190376513089LIF Osteotome, Curved 14mm

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