ANCHOR FS™ Facet Fixation System

GUDID 00643169099418

SCREW PFF0035 35MM FACET FIXATION ANCHOR

MEDTRONIC SOFAMOR DANEK, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00643169099418
NIH Device Record Key9bc77021-87e4-425c-8074-2bb8ebe59fe4
Commercial Distribution StatusIn Commercial Distribution
Brand NameANCHOR FS™ Facet Fixation System
Version Model NumberPFF0035
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 Usetrue
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(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter
Outer Diameter35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169099418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRWSYSTEM, FACET SCREW SPINAL DEVICE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2015-06-25

On-Brand Devices [ANCHOR FS™ Facet Fixation System]

00643169099425SCREW PFF0040 40MM FACET FIXATION ANCHOR
00643169099418SCREW PFF0035 35MM FACET FIXATION ANCHOR
00643169099401SCREW PFF0030 30MM FACET FIXATION ANCHOR
00643169099395SCREW PFF0025 25MM FACET FIXATION ANCHOR

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