Foot Osteotomy Wedge System 08.844.105S

GUDID 00819917028058

Tyber Medical LLC

Metallic osteotomy fusion cage, sterile

• Primary Device ID: 00819917028058
• NIH Device Record Key: 1fc071e9-11f3-4fb7-97a7-1878cb90f7e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foot Osteotomy Wedge System
• Version Model Number: 08.844.105S
• Catalog Number: 08.844.105S
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819917028058 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-28
• Device Publish Date: 2019-03-20

On-Brand Devices [Foot Osteotomy Wedge System]

• 00819917028379: Evans Osteotomy Trial, 22mm x 12mm
• 00819917028362: Evans Osteotomy Trial, 20mm x 12mm
• 00819917028355: Evans Osteotomy Trial, 20mm x 10mm
• 00819917028348: Evans Osteotomy Trial, 20mm x 8mm
• 00819917028331: Cotton Osteotomy Trial, 20mm x 6.5mm
• 00819917028324: Cotton Osteotomy Trial, 20mm x 5.5mm
• 00819917028317: Cotton Osteotomy Trial, 20mm x 4.5mm
• 00819917028300: Ø2.4mm Pin (6")
• 00819917028294: Straight Rod Inserter
• 00819917028249: Evans Osteotomy Trial, 18mm x 8mm
• 00819917028232: Evans Osteotomy Trial, 18mm x 10mm
• 00819917028225: Cotton Osteotomy Trial, 16mm x 5.5mm
• 00819917028195: Cotton Osteotomy Trial, 16mm x 4.5mm
• 00819917021875: Evans Osteotomy Trial, 22mm x 10mm
• 00819917028270: Hintermann Distractor
• 00819917028263: “V” Tamp 6”
• M695GTPC14955S0: ACIF TyPEEK 14mm x 9mm x 5 deg Straight
• M695GTPC14855S0: ACIF TyPEEK 14mm x 8mm x 5 deg Straight
• M695GTPC14755S0: ACIF TyPEEK 14mm x 7mm x 5 deg Straight
• M695GTPC14655S0: ACIF TyPEEK 14mm x 6mm x 5 deg Straight
• M695GTPC14555S0: ACIF TyPEEK 14mm x 5mm x 5 deg Straight
• M695GTPC141255S0: ACIF TyPEEK 14mm x 12mm x 5 deg Straight
• M695GTPC141155S0: ACIF TyPEEK 14mm x 11mm x 5 deg Straight
• M695GTPC141055S0: ACIF TyPEEK 14mm x 10mm x 5 deg Straight
• M6951407120: CerviFuse Lordotic Spacer, 11 x 14 x 12mm
• M6951407110: CerviFuse Lordotic Spacer, 11 x 14 x 11mm
• M6951407100: CerviFuse Lordotic Spacer, 11 x 14 x 10mm
• M6951407090: CerviFuse Lordotic Spacer, 11 x 14 x 9mm
• M6951407080: CerviFuse Lordotic Spacer, 11 x 14 x 8mm
• M6951407070: CerviFuse Lordotic Spacer, 11 x 14 x 7mm
• M6951407060: CerviFuse Lordotic Spacer, 11 x 14 x 6mm
• M6951407050: CerviFuse Lordotic Spacer, 11 x 14 x 5mm
• 00819917028386: Wedge Instrument Graphic Case
• 00819917028218: Cotton Osteotomy Trial, 16mm x 6.5mm
• 00819917028201: Cotton Osteotomy Trial, 16mm x 5.5mm
• 00819917028287: Evans Osteotomy Trial, 18mm x 12mm
• 00819917028188: 08.844.312S
• 00819917028171: 08.844.310S
• 00819917028164: 08.844.308S
• 00819917028157: 08.844.212S
• 00819917028140: 08.844.210S
• 00819917028133: 08.844.208S
• 00819917028126: 08.844.206S
• 00819917028119: 08.844.205S
• 00819917028102: 08.844.204S
• 00819917028096: 08.844.112S
• 00819917028089: 08.844.110S
• 00819917028072: 08.844.108S
• 00819917028065: 08.844.106S
• 00819917028058: 08.844.105S