Intervertebral Disc Preparation Instruments

GUDID 00190376675657

LIF Main A (Kleimeyer)

ALPHATEC SPINE, INC.

Instrument tray, reusable
Primary Device ID00190376675657
NIH Device Record Key53aa9d61-78d4-4b8d-b3cf-908d9d638141
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntervertebral Disc Preparation Instruments
Version Model NumberSSJKPTP1
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190376675657 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

[00190376675657]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-05
Device Publish Date2025-04-25

On-Brand Devices [Intervertebral Disc Preparation Instruments]

00190376394411LIF, RASP, CC OFFSET, 22MM
00190376394404LIF, RASP, CC OFFSET, 20MM
00190376394398LIF, RASP, CC OFFSET, 18MM
00190376394381LIF, RASP, CC OFFSET, 16MM
00190376394374LIF, RASP, CC OFFSET, 14MM
00190376394367LIF, RASP, CC OFFSET, 12MM
00190376394350LIF, RASP, CC OFFSET, 10MM
00190376394343LIF, RASP, STRAIGHT, SINGLE SIDED, 24MM
00190376394336LIF, RASP, STRAIGHT, SINGLE SIDED, 22MM
00190376394329LIF, RASP, STRAIGHT, SINGLE SIDED, 20MM
00190376394312LIF, RASP, STRAIGHT, SINGLE SIDED, 18MM
00190376394305LIF, RASP, STRAIGHT, SINGLE SIDED, 16MM
00190376394299LIF, RASP, STRAIGHT, SINGLE SIDED, 14MM
00190376394282LIF, RASP, STRAIGHT, SINGLE SIDED, 12MM
00190376394275LIF, RASP, STRAIGHT, SINGLE SIDED, 10MM
00190376394268LIF, RASP, STRAIGHT, 24MM
00190376394251LIF, RASP, STRAIGHT, 22MM
00190376394244LIF, RASP, STRAIGHT, 20MM
00190376394237LIF, RASP, STRAIGHT, 18MM
00190376394220LIF, RASP, STRAIGHT, 16MM
00190376394213LIF, RASP, STRAIGHT, 14MM
00190376394206LIF, RASP, STRAIGHT, 12MM
00190376394190LIF, RASP, STRAIGHT, 10MM
00190376394183LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 22MM
00190376394176LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 20MM
00190376394169LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 18MM
00190376394152LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 16MM
00190376394145LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 14MM
00190376394138LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 12MM
00190376394121LIF, ENDPLATE SCRAPER, MEDIAL DOWN, ANGLED, 10MM
00190376394114LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 22MM
00190376394107LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 20MM
00190376394091LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 18MM
00190376394084LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 16MM
00190376394077LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 14MM
00190376394060LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 12MM
00190376394053LIF, ENDPLATE SCRAPER, MEDIAL UP, ANGLED, 10MM
00190376394046LIF, ENDPLATE SCRAPER, MEDIAL, 22MM
00190376394039LIF, ENDPLATE SCRAPER, MEDIAL, 20MM
00190376394022LIF, ENDPLATE SCRAPER, MEDIAL, 18MM
00190376394015LIF, ENDPLATE SCRAPER, MEDIAL, 16MM
00190376394008LIF, ENDPLATE SCRAPER, MEDIAL, 14MM
00190376393995LIF, ENDPLATE SCRAPER, MEDIAL, 12MM
00190376393988LIF, ENDPLATE SCRAPER, MEDIAL, 10MM
00190376393971LIF, ENDPLATE SCRAPER, CRANIAL, ANGLED, 22MM
00190376393964LIF, ENDPLATE SCRAPER, CRANIAL, ANGLED, 20MM
00190376393957LIF, ENDPLATE SCRAPER, CRANIAL, ANGLED, 18MM
00190376393940LIF, ENDPLATE SCRAPER, CRANIAL, ANGLED, 16MM
00190376393933LIF, ENDPLATE SCRAPER, CRANIAL, ANGLED, 14MM
00190376393926LIF, ENDPLATE SCRAPER, CRANIAL, ANGLED, 12MM
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