RIPTIDE 6ZBZE2108

GUDID 00196449002313

Evans Wedge 21x17.5x8mm

Tyber Medical LLC

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00196449002313
• NIH Device Record Key: 1badbd2a-96a1-4884-8d4c-7f087e9ebbed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIPTIDE
• Version Model Number: 6ZBZE2108
• Catalog Number: 6ZBZE2108
• 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: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00196449002313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150394

FDA Product Code

• PLF: Bone Wedge

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-20
• Device Publish Date: 2022-07-12

On-Brand Devices [RIPTIDE]

• 00196449002450: Outer Case Lid
• 00196449002443: Outer Case
• 00196449002412: Evans Wedge 24x20x12mm
• 00196449002405: Evans Wedge 24x20x11mm
• 00196449002399: Evans Wedge 24x20x10mm
• 00196449002382: Evans Wedge 24x20x9mm
• 00196449002375: Evans Wedge 24x20x8mm
• 00196449002368: Evans Wedge 24x20x7mm
• 00196449002351: Evans Wedge 21x17.5x12mm
• 00196449002344: Evans Wedge 21x17.5x11mm
• 00196449002337: Evans Wedge 21x17.5x10mm
• 00196449002320: Evans Wedge 21x17.5x9mm
• 00196449002313: Evans Wedge 21x17.5x8mm
• 00196449002306: Evans Wedge 21x17.5x7mm
• 00196449002290: Evans Wedge 18x15x12mm
• 00196449002283: Evans Wedge 18x15x11mm
• 00196449002276: Evans Wedge 18x15x10mm
• 00196449002269: Evans Wedge 18x15x9mm
• 00196449002252: Evans Wedge 18x15x8mm
• 00196449002245: Evans Wedge 18x15x7mm
• 00196449002238: Cotton Wedge 25x15x8mm
• 00196449002221: Cotton Wedge 25x15x7mm
• 00196449002214: Cotton Wedge 25x15x6.5mm
• 00196449002207: Cotton Wedge 25x15x6mm
• 00196449002191: Cotton Wedge 25x15x5mm
• 00196449002184: Cotton Wedge 25x15x4.5mm
• 00196449002177: Cotton Wedge 25x15x4mm
• 00196449002160: Cotton Wedge 20x15x8mm
• 00196449002153: Cotton Wedge 20x15x7mm
• 00196449002146: Cotton Wedge 20x15x6.5mm
• 00196449002139: Cotton Wedge 20x15x6mm
• 00196449002122: Cotton Wedge 20x15x5mm
• 00196449002115: Cotton Wedge 20x15x4.5mm
• 00196449002108: Cotton Wedge 20x15x4mm
• 00196449002092: Cotton Wedge 15x15x8mm
• 00196449002085: Cotton Wedge 15x15x7mm
• 00196449002078: Cotton Wedge 15x15x6.5mm
• 00196449002061: Cotton Wedge 15x15x6mm
• 00196449002054: Cotton Wedge 15x15x5mm
• 00196449002047: Cotton Wedge 15x15x4.5mm
• 00196449002030: Cotton Wedge 15x15x4mm
• 00196449010073: Inserter single use
• 00196449002436: Evans Instrument Kit Sterile
• 00196449002429: Cotton Instrument Kit Sterile