Vault C ACDF System 37-CL-4208

GUDID 00840019904346

14 x 12 x 08mm 7° Posterior Cage

PRECISION SPINE, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00840019904346
NIH Device Record Key73f933c1-f785-4c6f-9d56-735cab810010
Commercial Distribution StatusIn Commercial Distribution
Brand NameVault C ACDF System
Version Model Number37-CL-4208
Catalog Number37-CL-4208
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 Usetrue
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
GS100840019904346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019904346]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-04-05

On-Brand Devices [Vault C ACDF System]

00840019917254Implant Insertion Tip Caddy
00840019917230Instrument Sterilization Case
00840019917223Implant Sterilization Case Assembly (All Caddies Included)
00840019917216Implant - Screw Caddy
00840019917209Implant - 18 x 15 Caddy
00840019917193Implant - 16 x 14 Caddy
00840019917186Implant - 14 x 12 Caddy
00840019917179Implant Sterilization Case
00840019917148Cage Inserter
00840019917124Torque Locking Handle
00840019917117Angled Bone Drill - 12mm
00840019917100Angled Self-Retaining Driver (2)
00840019917056Drill Guide
00840019917049Angled Awl
00840019917032Freehand Drill Guide
00840019917025Straight Awl
00840019917018Impaction/Extraction Mallet
00840019917001Implant Extraction Hook
00840019916998Bone Graft Compactor
00840019916981Implant Assembly Block
00840019916974Self-Retaining Drivers (2)
00840019916967Implant Insertion Tamp
00840019916950Guided Insertion Tip - 12mm
00840019916943Guided Insertion Tip - 11mm
00840019916905Guided Insertion Tip - 07mm
00840019916899Guided Insertion Tip - 06mm
00840019916875Implant Insertion Handle
00840019916868Rasp, 7° Lordosis, 18x15 - 11/12mm
00840019916851Rasp, 7° Lordosis, 18x15 - 9/10mm
00840019916844Rasp, 7° Lordosis, 18x15 - 7/8mm
00840019916837Rasp, 7° Lordosis, 18x15 - 5/6mm
00840019916820Rasp, 7° Lordosis, 16x14 - 11/12mm
00840019916813Rasp, 7° Lordosis, 16x14 - 9/10mm
00840019916806Rasp, 7° Lordosis, 16x14 - 7/8mm
00840019916769Rasp, 7° Lordosis, 14x12 - 7/8mm
00840019916752Rasp, 7° Lordosis, 14x12 - 5/6mm
00840019916745Rasp, 0° Lordosis, 18x15 - 11/12mm
00840019916738Rasp, 0° Lordosis, 18x15 - 9/10mm
00840019916714Rasp, 0° Lordosis, 18x15 - 5/6mm
0084001991670737-RS-0612
00840019916691Rasp, 0° Lordosis, 16x14 - 9/10mm
00840019916684Rasp, 0° Lordosis, 16x14 - 7/8mm
00840019916677Rasp, 0° Lordosis, 16x14 - 5/6mm
00840019916653Rasp, 0° Lordosis, 14x12 - 9/10mm
00840019916639Rasp, 0° Lordosis, 14x12 - 5/6mm
00840019916608Trial, 7° Lordosis, 18x15 - 7/8mm
00840019916592Trial, 7° Lordosis, 18x15 - 5/6mm
00840019916585Trial, 7° Lordosis, 16x14 - 11/12mm
00840019916578Trial, 7° Lordosis, 16x14 - 9/10mm
00840019916561Trial, 7° Lordosis, 16x14 - 7/8mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.