TenoTac Soft Tissue Fixation System P42-122-0100

GUDID 00889795053602

TenoTac Female, LONG 4.5 x 2.2 x 10mm

PARAGON 28, INC.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00889795053602
• NIH Device Record Key: dcd8eb52-32cf-4cf2-ba5b-fba0bf6c4888
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TenoTac Soft Tissue Fixation System
• Version Model Number: P42-122-0100
• Catalog Number: P42-122-0100
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• 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	00889795053602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182898

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

Sterilization

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

[00889795053602]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-25
• Device Publish Date: 2019-10-17

On-Brand Devices [TenoTac Soft Tissue Fixation System]

• 00889795053671: K-Wire, Single Ended Trocar Tip, SMOOTH, 0.9 x 100mm
• 00889795053640: TenoTac Female Implant Depth Gauge
• 00889795053633: TenoTac Female Implant Driver, T15
• 00889795053626: TenoTac Male Implant Inserter, T15
• 00889795053602: TenoTac Female, LONG 4.5 x 2.2 x 10mm
• 00889795053596: TenoTac Female, MED 4.5 x 2.2 x 7.5mm
• 00889795053589: TenoTac Female, SHORT, 4.5 x 2.2 x 5mm
• 00889795053572: TenoTac Male, 6 x 2.2 x 6.5mm
• 00889795053565: TenoTac Caddy Lid
• 00889795053558: TenoTac Caddy Base
• 00889795053619: TenoTac ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long
• 00889795114549: STERILE-Male Implant
• 00889795114532: STERILE-Female Implant, Long
• 00889795114525: STERILE-Female Implant, Short
• 00889795114518: TenoTac Sterile Kit System, Ø8mm x 2.2mm x 7.5mm
• 00889795100023: TenoTac Caddy Lid
• 00889795100016: TenoTac Caddy Base
• 00889795057280: (Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long
• 00889795057273: TenoTac Male Implant ø8mm x 2.2mm x 10mm Long
• 00889795057266: TenoTac Single Use ø2.8mm Cannulated Drill, ø8.0mm Countersink, 25mm Long
• 00889795057259: TenoTac Single Use ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long
• 00889795057242: TenoTac Single Use Female Implant Length Gauge 1st
• 00889795057235: TenoTac Single Use Female Implant Length Gauge 2nd, 3rd, 4th
• 00889795057228: TenoTac Single Use Female Implant Driver, T15
• 00889795057211: TenoTac Single Use Male Implant Inserter T15 Driver, 40mm Inserter Wire
• 00889795057204: (Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long Sterile Packaged
• 00889795057198: (Long) TenoTac Female Implant ø4.5mm x 2.2mm x 10mm Long Sterile Packaged
• 00889795057181: (Medium) TenoTac Female Implant ø4.5mm x 2.2mm x 7.5mm Long Sterile Packaged
• 00889795057174: (Short) TenoTac Female Implant ø4.5mm x 2.2mm x 5mm Long Sterile Packaged
• 00889795057167: TenoTac Male Implant ø8mm x 2.2mm x 10mm Long Sterile Packaged
• 00889795057150: TenoTac Male Implant ø6mm x 2.2mm x 6.5mm Long Sterile Packaged
• 00889795057143: TenoTac Sterile Kit 1st Digit BOM (diameter 8.0mm male x 10.0mm long)
• 00889795057136: TenoTac Sterile Kit 2nd, 3rd, 4th Digit BOM (diameter 6.0mm male x 6.5mm long)