PCM

GUDID 00887517605191

PCM Trial, 5.9mm Medium

Nuvasive, Inc.

Orthopaedic broach
Primary Device ID00887517605191
NIH Device Record Keye43ef8c3-d807-49d6-ae7d-9fbc2fc21222
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCM
Version Model Number7691359
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 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(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com
Phone+1800-475-9131
Emailnuvainfo@globusmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517605191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOPROSTHESIS, INTERVERTEBRAL DISC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887517605191]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-17

On-Brand Devices [PCM]

00887517525178Terraced Reamer General Instrument Set
00887517521118PCM Instrument Set
00887517521095PCM Implant Set
00887517084071PCM Trial, 8.0 mm Cervical Disc, Large
00887517084064PCM Trial, 7.2 mm Cervical Disc, Large
00887517084057PCM Trial, 6.5mm Cervical Disc, Large
00887517084040PCM Trial, 8.0 mm Cervical Disc, Medium
00887517084033PCM Trial, 7.2 mm Cervical Disc, Medium
00887517084026PCM Trial, 6.5mm Cervical Disc, Medium
00887517084019PCM Trial, 8.0 mm Cervical Disc, Small
00887517084002PCM Trial, 7.2 mm Cervical Disc, Small
00887517083593PCM Trial, 6.5mm Cervical Disc, Small
00887517083579PCM Driver, Final (US)
00887517083562PCM Inserter
00887517083555PCM Loading Block
00887517083166PCM Driver, Caspar Pin (US)
00887517083159PCM Guide, 12mm Distraction Screw (US)
00887517083142PCM Guide, 10mm Distraction Screw (US)
00887517083135PCM Spacer Wedge, 8.0mm (US)
00887517083128PCM Spacer Wedge, 6.5mm (US)
00887517083111PCM Cervical Disc Sterilization Tray Nipple Mat
00887517083104PCM Cervical Disc Instrument Tray, Bottom
00887517082596PCM Cervical Disc Instrument Tray, Middle
00887517082589PCM Cervical Disc Instrument Tray, Top
00887517082572PCM Cervical Disc Instrument Case Lid
00887517082565PCM Cervical Disc Instrument Case Base
00887517081605Artificial Vertebral Disc, 8.0 mm Large
00887517081193Artificial Vertebral Disc, 7.2 mm Large
00887517081186Artificial Vertebral Disc, 6.5 mm Large
00887517081179Artificial Vertebral Disc, 8.0 mm Medium
00887517081162Artificial Vertebral Disc, 7.2 mm Medium
00887517081155Artificial Vertebral Disc, 6.5 mm Medium
00887517081148Artificial Vertebral Disc, 8.0 mm Small
00887517081131Artificial Vertebral Disc, 7.2 mm Small
00887517081124Artificial Vertebral Disc, 6.5mm Small
00887517080752PCM Kerrison, 8.0mm Rim Wedge
00887517080745PCM Kerrison, 7.2mm Rim Wedge
00887517080738PCM Kerrison, 6.5mm Rim Wedge
00887517080721PCM Kerrison, 5.7mm Rim Wedge
00887517079046PCM Guide, Burr Sterile Rim
00887517079039PCM Kerrison, Rim
00887517079008PCM Broach, 5.7/6.5 Medium Modular
00887517078599PCM Broach, 5.7/6.5 Small Modular
00887517078551PCM Handle, Modular
00887517078544PCM Drill, Modular Flange
00887517078537PCM Screwdriver, Fixation
00887517077349PCM Driver, Final
00887517076502PCM Guide, Spacer Wedge
00887517075994PCM Guide, Spacer Wedge
00887517075987PCM Guide, Distraction Screw
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