Simpact 152-08-645

GUDID 00190837101541

SI Screw, Lag, 8mm x 45mm

Life Spine, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00190837101541
• NIH Device Record Key: 5c0f22e6-09d2-4de4-8ae3-23345d429bf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpact
• Version Model Number: 152-08-645
• Catalog Number: 152-08-645
• 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: false
• 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	00190837101541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180749

FDA Product Code

• OUR: Sacroiliac joint fixation

Sterilization

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

[00190837101541]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [Simpact]

• 00190837095369: 8.0mm Drill, Cannulated, Short
• 00190837089245: Pin Holder
• 00190837089238: 8.0mm Drill, Cannulated
• 00190837089221: 300mm x 2.4mm Steinmann Pin, Trocar-Blunt, CoCr
• 00190837089214: 300mm x 2.4mm Steinmann Pin, Threaded-Blunt, CoCr
• 00190837089191: 300mm x 2.4mm Steinmann Pin, Threaded-Blunt, 17.4 SS
• 00190837089184: SImpact 12mm Screw Caddy
• 00190837083946: 154-170
• 00190837079666: 90 degree Cup Curette, Right #2, 10mm Tip
• 00190837079659: 90 degree Cup Curette, Left #2, 10mm Tip
• 00190837079642: 530mm x 2.4mm Steinmann Pin, Blunt-Blunt, Stainless Steel
• 00190837079635: Cannula Cleaner, Stainless Steel
• 00190837079222: Locking Screw Driver
• 00190837075590: Triangular Pin Offset Guide, 16-16-18
• 00190837075583: 16mm Triangular Pin Offset Guide
• 00190837075576: 16mm Parallel Pin Offset Guide
• 00190837075569: 8.0mm Drill, Cannulated
• 00190837075552: 14mm Parallel Pin Offset Guide
• 00190837071318: SImpact Instrument Tray, Lid
• 00190837071301: Simpact Implant Tray, Base
• 00190837071295: SImpact Implant Tray, Lower Tray
• 00190837071288: SImpact Implant Tray, Lid
• 00190837071271: SImpact System- Instrument Tray
• 00190837071264: SImpactSystem- Implant Tray
• 00190837071257: LARGE QUICK CONNECT HANDLE
• 00190837101572: SI Screw, Lag, 8mm x 60mm
• 00190837101565: SI Screw, Lag, 8mm x 55mm
• 00190837101558: SI Screw, Lag, 8mm x 50mm
• 00190837101541: SI Screw, Lag, 8mm x 45mm
• 00190837101534: SI Screw, Lag, 8mm x 40mm
• 00190837101527: SI Screw, Lag, 8mm x 35mm