Intervertebral Body Fusion Device 50-0004

GUDID 00840019925099

AccuFit™ RP System Case (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019925099
NIH Device Record Keyda65de9a-0516-4efb-bb43-8b223bbf1225
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntervertebral Body Fusion Device
Version Model Number50-0004
Catalog Number50-0004
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019925099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019925099]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [Intervertebral Body Fusion Device ]

00840019925105Tray
00840019925099AccuFit™ RP System Case (Empty)
00840019925075Straight Awl ALIF Stabilizer
00840019925068Install Guide ALIF Stabilizer 17mm
00840019925051Install Guide ALIF Stabilizer 15mm
00840019925044Install Guide ALIF Stabilizer 13mm
00840019925037Install Guide ALIF Stabilizer 11mm
00840019925013Universal Driver ALIF Stabilizer 3.25mm
00840019925006Awl Fixed 30 degree ALIF Stabilizer
00840019924986ShurFit™ ALIF Implant Case # 3 (Empty)
00840019924979ShurFit™ ALIF Implant Case # 2 (Empty)
00840019924962ShurFit™ ALIF Implant Case # 1 (Empty)
00840019924955ShurFit™ ALIF Instrument Case # 3 (Empty)
00840019924948ShurFit™ ALIF Instrument Case # 2 (Empty)
00840019924924ALIF Sizer 15 degree 21mm x 39mm
00840019924917ALIF Sizer 15 degree 19mm x 39mm
00840019924900ALIF Sizer 15 degree 17mm x 39mm
00840019924894ALIF Sizer 15 degree 15mm x 39mm
00840019924887ALIF Sizer 15 degree 13mm x 39mm
00840019924863ALIF Sizer 8 degree 21mm x 39mm
00840019924849ALIF Sizer 8 degree 17mm x 39mm
00840019924832ALIF Sizer 8 degree 15mm x 39mm
00840019924818ALIF Sizer 8 degree 11mm x 39mm
00840019924795ALIF Sizer 15 degree 21mm x 32mm
00840019924788ALIF Sizer 15 degree 19mm x 32mm
00840019924764ALIF Sizer 15 degree 15mm x 32mm
00840019924757ALIF Sizer 15 degree 13mm x 32mm
00840019924740ALIF Sizer 15 degree 11mm x 32mm
00840019924726ALIF Sizer 8 degree 19mm x 32mm
00840019924719ALIF Sizer 8 degree 17mm x 32mm
00840019924702ALIF Sizer 8 degree 15mm x 32mm
00840019924696ALIF Sizer 8 degree 13mm x 32mm
00840019924689ALIF Sizer 8 degree 11mm x 32mm
00840019924672ALIF Sizer 8 degree 9mm x 32mm
00840019924658ALIF Sizer 15 degree 21mm x 26mm
00840019924641ALIF Sizer 15 degree 19mm x 26mm
00840019924627ALIF Sizer 15 degree 15mm x 26mm
00840019924610ALIF Sizer 15 degree 13mm x 26mm
0084001992459700-901608-21
00840019924580ALIF Sizer 8 degree 19mm x 26mm
00840019924573ALIF Sizer 8 degree 17mm x 26mm
00840019924566ALIF Sizer 8 degree 15mm x 26mm
00840019924559ALIF Sizer 8 degree 13mm x 26mm
00840019924542ALIF Sizer 8 degree 11mm x 26mm
00840019924528Volt Inserter Gator Intech Green
00840019924511Rongeur
00840019924504Distractor
00840019924481Curette
00840019924474Curette
00840019924450Curette

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