Simpact
GUDID 00190837146634
Life Spine, Inc.
Orthopaedic bone screw, non-bioabsorbable, sterile| Primary Device ID | 00190837146634 |
| NIH Device Record Key | d6861a70-5ac2-4c94-91ac-3f2e312ff5de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simpact |
| Version Model Number | 152-12-9301 |
| 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 | 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 | 00190837146634 [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 | true |
[00190837146634]
Radiation Sterilization
[00190837146634]
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[00190837146634]
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[00190837146634]
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[00190837146634]
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[00190837146634]
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[00190837146634]
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[00190837146634]
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[00190837146634]
Radiation Sterilization
[00190837146634]
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[00190837146634]
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[00190837146634]
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[00190837146634]
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Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-01 |
| Device Publish Date | 2021-11-23 |
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 |
| 00190837119072 | 152-14-960 |
| 00190837119065 | 152-14-955 |
| 00190837119058 | 152-14-950 |
| 00190837119041 | 152-14-945 |
| 00190837119034 | 152-14-940 |
| 00190837119027 | 152-14-935 |
| 00190837119010 | 152-14-930 |
| 00190837119096 | 152-14-970 |
| 00190837119089 | 152-14-965 |
| 00190837146719 | 152-12-9701 |
| 00190837146702 | 152-12-9651 |
| 00190837146696 | 152-12-9601 |
| 00190837146689 | 152-12-9551 |
| 00190837146672 | 152-12-9501 |
| 00190837146665 | 152-12-9451 |
| 00190837146658 | 152-12-9401 |
| 00190837146641 | 152-12-9351 |
| 00190837146634 | 152-12-9301 |
| 00190837155902 | 2022-0034 |
Trademark Results [Simpact]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPACT 90247289 not registered Live/Pending |
Simpact Technology BV 2020-10-11 |
 SIMPACT 90247156 not registered Live/Pending |
Simpact Technology BV 2020-10-11 |
 SIMPACT 87238630 5429320 Live/Registered |
Life Spine, Inc. 2016-11-16 |
 SIMPACT 86632576 not registered Dead/Abandoned |
Life Spine, Inc. 2015-05-18 |
 SIMPACT 86008076 4478247 Live/Registered |
Smooth-On, Inc. 2013-07-11 |
 SIMPACT 85552528 4455682 Live/Registered |
SIMPACT STRATEGY GROUP INC. 2012-02-24 |
 SIMPACT 85011983 4163051 Live/Registered |
SiMPACT STRATEGY GROUP INC. 2010-04-12 |
 SIMPACT 77978460 3797519 Live/Registered |
SIMPACT, LLC 2008-02-21 |
 SIMPACT 77978308 3797518 Live/Registered |
SIMPACT, LLC 2008-02-21 |
 SIMPACT 77402532 4168179 Dead/Cancelled |
Appollonia LLC 2008-02-21 |
 SIMPACT 77402515 4168178 Dead/Cancelled |
Appollonia LLC 2008-02-21 |
 SIMPACT 75792210 2488819 Dead/Cancelled |
Ssangyong Precision Industry Co., Ltd. 1999-09-03 |
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