P-tanium Wedge TOCOTW154P-S

GUDID M695TOCOTW154PS0

Wedge TYPEEK Cotton - 16mm x 4.5mm

Tyber Medical LLC

Polymeric osteotomy fusion cage, non-customized
Primary Device IDM695TOCOTW154PS0
NIH Device Record Keyba2a8b08-60f9-497c-834a-578c23f79bd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameP-tanium Wedge
Version Model NumberTOCOTW154P-S
Catalog NumberTOCOTW154P-S
Company DUNS010968002
Company NameTyber Medical LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com
Phone+1(866)761-0933
Emailksimpkins@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM695TOCOTW154PS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-06-08
Device Publish Date2019-08-23

On-Brand Devices [P-tanium Wedge]

M695TOEVNW229PS0Wedge TYPEEK Evans - 22mm x 22mm x 10mm
M695TOEVNW227PS0Wedge TYPEEK Evans - 22mm x 22mm x 8mm
M695TOEVNW2211PS0Wedge TYPEEK Evans - 22mm x 22mm x 12mm
M695TOEVNW209PS0Wedge TYPEEK Evans - 20mm x 20mm x 10mm
M695TOEVNW207PS0Wedge TYPEEK Evans - 20mm x 20mm x 8mm
M695TOEVNW2011PS0Wedge TYPEEK Evans - 20mm x 20mm x 12mm
M695TOEVNW189PS0Wedge TYPEEK Evans - 18mm x 18mm x 10mm
M695TOEVNW187PS0Wedge TYPEEK Evans - 18mm x 18mm x 8mm
M695TOEVNW1811PS0Wedge TYPEEK Evans - 18mm x 18mm x 12mm
M695TOCOTW197PS0Wedge TYPEEK Cotton - 20mm x 6.5mm
M695TOCOTW195PS0Wedge TYPEEK Cotton - 20mm x 5.5mm
M695TOCOTW194PS0Wedge TYPEEK Cotton - 20mm x 4.5mm
M695TOCOTW157PS0Wedge TYPEEK Cotton - 16mm x 6.5mm
M695TOCOTW155PS0Wedge TYPEEK Cotton - 16mm x 5.5mm
M695TOCOTW154PS0Wedge TYPEEK Cotton - 16mm x 4.5mm

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