Simpact Tri-Fin 152-12-635

GUDID 00190837062798

SI Compression Screw, Slotted, 12mm x 35mm

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837062798
• NIH Device Record Key: f23707b9-93e1-4d59-b06c-6335d477d5be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpact Tri-Fin
• Version Model Number: 152-12-635
• Catalog Number: 152-12-635
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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: 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	00190837062798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141246

FDA Product Code

• OUR: Sacroiliac joint fixation

Sterilization

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

[00190837062798]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Simpact Tri-Fin]

• 00190837020743: 152-12-970
• 00190837020736: 152-12-965
• 00190837020729: 152-12-960
• 00190837020712: 152-12-955
• 00190837020705: 152-12-950
• 00190837020699: 152-12-945
• 00190837020682: 152-12-940
• 00190837020675: 152-12-935
• 00190837020668: 152-12-930
• 00190837063337: Anterior Curette #1 Ang 9" Handle
• 00190837063320: Mallet 40mm Head 1lb 9oz - 9 1/2 Long
• 00190837063313: Initial Dilation Tube w/ Threads
• 00190837063306: 14mm Parallel Pin Offset Guide
• 00190837063290: Sleeve Drill, Short
• 00190837063283: Parallel Pin Offset Guide, Large Screw
• 00190837063276: Pin Holder, Long
• 00190837063269: 300mm x 2.4mm Steinmann Pin, Trocar-Flat, 17-4 SS
• 00190837063252: 530mm x 2.4mm Steinmann Pin, Flat-Flat, 17-4 SS
• 00190837063245: 300mm x 2.4 Steinmann Pin, Threaded-Blunt, CoCr
• 00190837063238: Pin Caddy, 300mm x 2.4mm, CoCr Pins
• 00190837063221: Steinmann Pin, 300mm x 2.4mm Trocar-Blunt, CoCr
• 00190837063214: Steinmann Pin, Threaded-Blunt Ends
• 00190837063207: #3 Dilation Tube, with handle
• 00190837063191: Locking Screw Driver
• 00190837063184: Locking Screw Driver
• 00190837063177: SImpact Tri-Fin Screw Driver Button
• 00190837063160: SImpact Tri-Fin Screw Driver
• 00190837063153: Sleeve Drill
• 00190837063146: 8.0mm Drill, Cannulated
• 00190837063139: Final Dilation Tube
• 00190837063122: Parallel Pin Offset Guide, Large Screw
• 00190837063115: PARALLEL PIN OFFSET GUIDE, SMALL SCREW
• 00190837063108: Triangular Pin Offset Guide, Large Screw
• 00190837063092: Final Dilation Tube
• 00190837063085: Depth Gage
• 00190837063078: 530mm x 2.4mm Steinmann Pin, Trocar-Blunt, 17-4 SS
• 00190837063061: 300mm x 2.4mm Steinmann Pin, Blunt-Blunt, 17-4 SS
• 00190837063054: 530mm x 2.4mm Steinmann Pin, Blunt-Blunt 17-4 SS
• 00190837063047: 530mm x 2.4mm Steinmann Pin, Threaded-Blunt 17-4 SS
• 00190837063030: Parallel Pin Offset Guide, Large Screw
• 00190837063023: Parallel Pin Offset Guide, Small Screw
• 00190837063016: Pin Holder
• 00190837063009: Large Mallet
• 00190837062996: Steinmann Pin Caddy, Long Blunt Pins
• 00190837062989: Steinmann Pin Caddy, Short Blunt Pins
• 00190837062972: Steinmann Pin Caddy, Long Trocar Pins
• 00190837062965: Steinmann Pin Caddy, Short Trocar Pins
• 00190837062958: Implant Remover
• 00190837062941: 1/4 Square Screw Driver, T30 Hexalobe
• 00190837062934: SI Screw Driver Sleeve