P-tanium Wedge TOEVNW2211P-S

GUDID M695TOEVNW2211PS0

Wedge TYPEEK Evans - 22mm x 22mm x 12mm

Tyber Medical LLC

Polymeric osteotomy fusion cage, non-customized

• Primary Device ID: M695TOEVNW2211PS0
• NIH Device Record Key: f69ef8dc-f14b-4364-9e67-e97ded8ff638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-tanium Wedge
• Version Model Number: TOEVNW2211P-S
• Catalog Number: TOEVNW2211P-S
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com
• Phone: +1(866)761-0933
• Email: ksimpkins@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695TOEVNW2211PS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150394

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-08
• Device Publish Date: 2019-08-23

On-Brand Devices [P-tanium Wedge]

• M695TOEVNW229PS0: Wedge TYPEEK Evans - 22mm x 22mm x 10mm
• M695TOEVNW227PS0: Wedge TYPEEK Evans - 22mm x 22mm x 8mm
• M695TOEVNW2211PS0: Wedge TYPEEK Evans - 22mm x 22mm x 12mm
• M695TOEVNW209PS0: Wedge TYPEEK Evans - 20mm x 20mm x 10mm
• M695TOEVNW207PS0: Wedge TYPEEK Evans - 20mm x 20mm x 8mm
• M695TOEVNW2011PS0: Wedge TYPEEK Evans - 20mm x 20mm x 12mm
• M695TOEVNW189PS0: Wedge TYPEEK Evans - 18mm x 18mm x 10mm
• M695TOEVNW187PS0: Wedge TYPEEK Evans - 18mm x 18mm x 8mm
• M695TOEVNW1811PS0: Wedge TYPEEK Evans - 18mm x 18mm x 12mm
• M695TOCOTW197PS0: Wedge TYPEEK Cotton - 20mm x 6.5mm
• M695TOCOTW195PS0: Wedge TYPEEK Cotton - 20mm x 5.5mm
• M695TOCOTW194PS0: Wedge TYPEEK Cotton - 20mm x 4.5mm
• M695TOCOTW157PS0: Wedge TYPEEK Cotton - 16mm x 6.5mm
• M695TOCOTW155PS0: Wedge TYPEEK Cotton - 16mm x 5.5mm
• M695TOCOTW154PS0: Wedge TYPEEK Cotton - 16mm x 4.5mm