PLIF Interbody System 20-502-P241088-S

GUDID M69520502P241088S0

PLIF TiPEEK 24mm x 8mm x 10mm x 8 deg

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: M69520502P241088S0
• NIH Device Record Key: 5341b11e-5c2a-4d2a-904c-557411acd186
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLIF Interbody System
• Version Model Number: 20-502-P241088-S
• Catalog Number: 20-502-P241088-S
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com
• Phone: +1(866)761-0933
• Email: jstigliano@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M69520502P241088S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130573

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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: 2020-02-24
• Device Publish Date: 2019-11-12

On-Brand Devices [PLIF Interbody System]

• M69520502P269810S0: PLIF TiPEEK 26mm x 10mm x 9mm x 8 deg
• M69520502P26888S0: PLIF TiPEEK 26mm x 8mm x 8mm x 8 deg
• M69520502P268810S0: PLIF TiPEEK 26mm x 10mm x 8mm x 8 deg
• M69520502P267810S0: PLIF TiPEEK 26mm x 10mm x 7mm x 8 deg
• M69520502P2612810S0: PLIF TiPEEK 26mm x 10mm x 12mm x 8 deg
• M69520502P2611810S0: PLIF TiPEEK 26mm x 10mm x 11mm x 8 deg
• M69520502P2610810S0: PLIF TiPEEK 26mm x 10mm x 10mm x 8 deg
• M69520502P24988S0: PLIF TiPEEK 24mm x 8mm x 9mm x 8 deg
• M69520502P241488S0: PLIF TiPEEK 24mm x 8mm x 14mm x 8 deg
• M69520502P241388S0: PLIF TiPEEK 24mm x 8mm x 13mm x 8 deg
• M69520502P241288S0: PLIF TiPEEK 24mm x 8mm x 12mm x 8 deg
• M69520502P241088S0: PLIF TiPEEK 24mm x 8mm x 10mm x 8 deg