FORZA PTC

GUDID 18257200092079

11W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE

ORTHOFIX INC.

Metallic spinal interbody fusion cage
Primary Device ID18257200092079
NIH Device Record Key9ebb0bf0-02a5-4436-b696-6242b794b77f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFORZA PTC
Version Model Number38-1812SP
Company DUNS927083808
Company NameORTHOFIX 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200092079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


[18257200092079]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-03-12

On-Brand Devices [FORZA PTC]

1825720011141111W X 27L X 11H, 0DEG STRAIGHT PTC IMPLANT, STERILE
182572001114049W X 23L X 10H, 0DEG STRAIGHT PTC IMPLANT, STERILE
1825720011130511W X 27L X 13H, 0DEG CURVED PTC IMPLANT, STERILE
182572000923219W X 27L X 14H, 8DEG CURVED PTC IMPLANT, STERILE
182572000923149W X 27L X 13H, 8DEG CURVED PTC IMPLANT, STERILE
182572000923079W X 27L X 12H, 8DEG CURVED PTC IMPLANT, STERILE
182572000922919W X 27L X 11H, 8DEG CURVED PTC IMPLANT, STERILE
182572000922849W X 27L X 10H, 8DEG CURVED PTC IMPLANT, STERILE
182572000922779W X 27L X 9H, 8DEG CURVED PTC IMPLANT, STERILE
182572000922609W X 27L X 8H, 8DEG CURVED PTC IMPLANT, STERILE
182572000922539W X 27L X 14H, 0DEG CURVED PTC IMPLANT, STERILE
182572000922469W X 27L X 13H, 0DEG CURVED PTC IMPLANT, STERILE
182572000922399W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE
182572000922229W X 27L X 11H, 0DEG CURVED PTC IMPLANT, STERILE
182572000922159W X 27L X 10H, 0DEG CURVED PTC IMPLANT, STERILE
182572000922089W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE
182572000921929W X 27L X 8H, 0DEG CURVED PTC IMPLANT, STERILE
182572000921859W X 27L X 7H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009217811W X 31L X 14H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009216111W X 31L X 13H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009215411W X 31L X 12H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009214711W X 31L X 11H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009213011W X 31L X 10H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009212311W X 31L X 9H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009211611W X 31L X 8H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009210911W X 31L X 7H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009209311W X 27L X 14H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009207911W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009206211W X 27L X 11H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009205511W X 27L X 10H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009204811W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009203111W X 27L X 8H, 0DEG CURVED PTC IMPLANT, STERILE
1825720009202411W X 27L X 7H, 0DEG CURVED PTC IMPLANT, STERILE
182572000920179W X 27L X 14H, 8DEG STRAIGHT PTC IMPLANT, STERILE
182572000920009W X 27L X 13H, 8DEG STRAIGHT PTC IMPLANT, STERILE
182572000919979W X 27L X 12H, 8DEG STRAIGHT PTC IMPLANT, STERILE
182572000919809W X 27L X 11H, 8DEG STRAIGHT PTC IMPLANT, STERILE
182572000919739W X 27L X 10H, 8DEG STRAIGHT PTC IMPLANT, STERILE
182572000919669W X 27L X 9H, 8DEG STRAIGHT PTC IMPLANT, STERILE
182572000919599W X 27L X 14H, 0DEG STRAIGH PTC IMPLANT, STERILE
182572000919429W X 27L X 13H, 0DEG STRAIGH PTC IMPLANT, STERILE
182572000919359W X 27L X 12H, 0DEG STRAIGH PTC IMPLANT, STERILE
182572000919289W X 27L X 11H, 0DEG STRAIGH PTC IMPLANT, STERILE
182572000919119W X 27L X 10H, 0DEG STRAIGH PTC IMPLANT, STERILE
182572000919049W X 27L X 9H, 0DEG STRAIGHT PTC IMPLANT, STERILE
182572000918989W X 27L X 8H, 0DEG STRAIGHT PTC IMPLANT, STERILE
182572000918819W X 27L X 7H, 0DEG STRAIGHT PTC IMPLANT, STERILE
1825720009187411W X 31L X 14H, 0DEG STRAIGHT PTC IMPLANT, STERILE
1825720009186711W X 31L X 13H, 0DEG STRAIGHT PTC IMPLANT, STERILE
1825720009185011W X 31L X 12H, 0DEG STRAIGHT PTC IMPLANT, STERILE

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