ProLift Pivot Expandable Spacer System
Life Spine, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004499989 | 3004499989 | LIFE SPINE | 1 | Y | 2026-01-01 | 13951 Quality Dr Huntley IL US 60142 |
| 3004499989 | 3004499989 | LIFE SPINE | 1 | N | 2020-04-25 | 13951 S Quality Drive Huntley IL US 60142 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 345405 | 1681987251 | K250373 | ProLift Expandable Spacer System | MAX | 2025-04-09 |
| 345405 | 2001825032 | K243668 | ProLift Pivot Expandable Spacer System | MAX | 2025-01-23 |
| 345405 | 1459115399 | K243369 | Cervical Plating System | KWQ | 2024-12-11 |
| 345405 | 1383273926 | K242826 | ProLift Wedge Expandable Spacer System | MAX | 2024-10-08 |
| 345405 | 2010084659 | K241464 | ARx® SAI Implant System | OUR | 2024-07-29 |
| 345405 | 1706935045 | K233455 | ARx MIS Spinal Screw System | NKB | 2023-12-12 |
| 345405 | 1593332455 | K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | MAX | 2023-11-30 |
| 345405 | 1368132860 | K231704 | Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System | OVE | 2023-10-19 |
| 345405 | 1782074413 | K223430 | ProLift Micro Expandable Spacer System | MAX | 2023-05-04 |
| 345405 | 1051029427 | K222628 | Life Spine ALIF Buttress Plate System | KWQ | 2022-11-16 |
| 345405 | 1108284177 | K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | MAX | 2022-12-05 |
| 345405 | 1595305725 | K220341 | ARx Modular Spinal System | NKB | 2022-05-02 |
| 345405 | 1008889063 | K213417 | Ghost Spacer System | MAX | 2022-09-29 |
| 345405 | 1206309584 | K212903 | SIMPACT Sacroiliac Joint Fixation System | OUR | 2021-12-15 |
| 345405 | 2036797021 | K212520 | ProLift Micro Expandable Spacer System | MAX | 2021-10-08 |
| 345405 | 1821757607 | K210549 | ARx Spinal System | NKB | 2021-04-22 |
| 345405 | 1156189256 | K210061 | ProLift Lateral HELO Fixated | MAX | 2021-04-30 |
| 345405 | 1652983292 | K203361 | ProLift Wedge Expandable Spacer System | MAX | 2021-03-17 |
| 345405 | 1145217252 | K203163 | ARx Illiac Spinal Screw System | NKB | 2020-12-17 |
| 345405 | 1477435365 | K202836 | GX Navigation Instrument System | OLO | 2021-08-19 |
| 345405 | 1134885523 | K201721 | TruLift Expandable Spacer System | MAX | 2020-09-04 |
| 345405 | 1060544132 | K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | OUR | 2020-09-18 |
| 345405 | 1975547177 | K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | MAX | 2020-08-04 |
| 345405 | 1323372281 | K200896 | Solstice CCI | NKG | 2020-04-28 |
| 345405 | 1188953755 | K200338 | ProLift Lateral Fixated | OVD | 2020-04-17 |
| 345405 | 1445825483 | K200070 | ARx Spinal System | NKB | 2020-04-23 |
| 63214 | 2015089576 | K193521 | Steerable Plateau Ti | MAX | 2020-02-06 |
| 345405 | 2015089576 | K193521 | Steerable Plateau Ti | MAX | 2020-02-06 |
| 63214 | 1509340385 | K193258 | ProLift Expandable System | MAX | 2020-01-31 |
| 345405 | 1509340385 | K193258 | ProLift Expandable System | MAX | 2020-01-31 |
| 63214 | 1459548811 | K191927 | Hinged Laminoplasty System | NQW | 2019-09-20 |
| 345405 | 1459548811 | K191927 | Hinged Laminoplasty System | NQW | 2019-09-20 |
| 63214 | 1961769199 | K191834 | Stand-Alone ALIF Titanium System | OVD | 2019-12-16 |
| 345405 | 1961769199 | K191834 | Stand-Alone ALIF Titanium System | OVD | 2019-12-16 |
| 345405 | 1291268641 | K191575 | ARx Spinal System | NKB | 2019-08-08 |
| 63214 | 1644631943 | K191005 | ProLift® Expandable System | MAX | 2019-06-13 |
| 345405 | 1644631943 | K191005 | ProLift® Expandable System | MAX | 2019-06-13 |
| 63214 | 2025224074 | K190721 | LongBow Ti | MAX | 2019-11-14 |
| 345405 | 2025224074 | K190721 | LongBow Ti | MAX | 2019-11-14 |
| 63214 | 1177646918 | K190488 | ProLift Expandable System | MAX | 2019-07-23 |
| 345405 | 1177646918 | K190488 | ProLift Expandable System | MAX | 2019-07-23 |
| 63214 | 1315978752 | K183430 | Modular Spinal Fixation System | NKB | 2019-03-13 |
| 345405 | 1315978752 | K183430 | Modular Spinal Fixation System | NKB | 2019-03-13 |
| 63214 | 1538103418 | K182470 | Plateau Spacer System | MAX | 2018-11-26 |
| 345405 | 1538103418 | K182470 | Plateau Spacer System | MAX | 2018-11-26 |
| 63214 | 1595169809 | K181717 | Life Spine Laminoplasty System | NQW | 2018-10-12 |
| 345405 | 1595169809 | K181717 | Life Spine Laminoplasty System | NQW | 2018-10-12 |
| 63214 | 1731581635 | K181625 | Life Spine Resolute™ Threaded Cage System | MAX | 2018-12-11 |
| 345405 | 1731581635 | K181625 | Life Spine Resolute™ Threaded Cage System | MAX | 2018-12-11 |
| 63214 | 1831137630 | K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | OUR | 2018-06-15 |
| 345405 | 1831137630 | K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | OUR | 2018-06-15 |
| 63214 | 2042139015 | K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | OVE | 2018-05-10 |
| 345405 | 2042139015 | K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | OVE | 2018-05-10 |
| 63214 | 1157353562 | K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | OVD | 2018-09-13 |
| 345405 | 1157353562 | K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | OVD | 2018-09-13 |
| 63214 | 1230577577 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | KWQ | 2018-06-22 |
| 345405 | 1230577577 | K180166 | Life Spine Lumbar Fixation System (SENTRY) | KWQ | 2018-06-22 |
| 63214 | 1772773380 | K173883 | External Fixation System | KTT | 2018-09-07 |
| 345405 | 1772773380 | K173883 | External Fixation System | KTT | 2018-09-07 |
| 63214 | 1940776995 | K173286 | Cannulated Screw Internal Fixation System | HWC | 2017-12-14 |
| 345405 | 1940776995 | K173286 | Cannulated Screw Internal Fixation System | HWC | 2017-12-14 |
| 63214 | 1007569475 | K173182 | ProLift® Expandable System | MAX | 2017-12-20 |
| 345405 | 1007569475 | K173182 | ProLift® Expandable System | MAX | 2017-12-20 |
| 63214 | 1739889737 | K172973 | Life Spine Foot and Ankle Plating System | HRS | 2017-12-21 |
| 345405 | 1739889737 | K172973 | Life Spine Foot and Ankle Plating System | HRS | 2017-12-21 |
| 63214 | 1591835816 | K172131 | 2 Hole Lateral Plating System | KWQ | 2017-08-28 |
| 345405 | 1591835816 | K172131 | 2 Hole Lateral Plating System | KWQ | 2017-08-28 |
| 63214 | 1093914186 | K172105 | The Plateau-LO Spacer System | MAX | 2018-02-02 |
| 345405 | 1093914186 | K172105 | The Plateau-LO Spacer System | MAX | 2018-02-02 |
| 63214 | 1520527202 | K171448 | Hammertoe Correction System | HWC | 2017-07-07 |
| 345405 | 1520527202 | K171448 | Hammertoe Correction System | HWC | 2017-07-07 |
| 63214 | 1372506242 | K170919 | The TiBow Expandable Spacer System | MAX | 2017-08-03 |
| 345405 | 1372506242 | K170919 | The TiBow Expandable Spacer System | MAX | 2017-08-03 |
| 63214 | 1136456167 | K170804 | The Solstice OCT System | NKG | 2017-05-18 |
| 345405 | 1136456167 | K170804 | The Solstice OCT System | NKG | 2017-05-18 |
| 345405 | 1910791439 | K162685 | 2-Piece Hammertoe Correction System | HWC | 2017-06-09 |
| 63214 | 1259684461 | K162266 | The Cranial Fusion System | NKG | 2017-05-01 |
| 345405 | 1259684461 | K162266 | The Cranial Fusion System | NKG | 2017-05-01 |
| 345405 | 1363336523 | K161279 | Life Spine Metatarsal Hemi Implant | KWD | 2017-02-01 |
| 63214 | 1177237294 | K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | ODP | 2016-12-22 |
| 345405 | 1177237294 | K161127 | The Small PLATEAU (PLATEAU-C) Spacer System | ODP | 2016-12-22 |
| 63214 | 1322281253 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | HRS | 2016-08-15 |
| 345405 | 1322281253 | K161037 | Tarsa-Link Stand-Alone Wedge Fixation System | HRS | 2016-08-15 |
| 345405 | 1493287857 | K160169 | The Life Spine Subtalar Implant System | HWC | 2016-06-23 |
| 63214 | 2032746731 | K160066 | Pro-Link® Stand-Alone Cervical Spacer System | OVE | 2016-09-02 |
| 345405 | 2032746731 | K160066 | Pro-Link® Stand-Alone Cervical Spacer System | OVE | 2016-09-02 |
| 63214 | 1385574927 | K153400 | ProLift Expandable System | MAX | 2016-03-07 |
| 345405 | 1385574927 | K153400 | ProLift Expandable System | MAX | 2016-03-07 |
| 345405 | 1346843926 | K153065 | The Hammertoe Correction System | HWC | 2016-08-01 |
| 63214 | 1052008891 | K152282 | Cam Lock Plating System | KWQ | 2015-11-20 |
| 345405 | 1052008891 | K152282 | Cam Lock Plating System | KWQ | 2015-11-20 |
| 345405 | 1641592743 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | 2015-07-07 |
| 63214 | 1204258249 | K151196 | Nautilus Spinal System | NKB | 2015-07-14 |
| 345405 | 1204258249 | K151196 | Nautilus Spinal System | NKB | 2015-07-14 |
| 63214 | 1768788775 | K150390 | Nautilus Spinal System | NKB | 2015-03-16 |
| 345405 | 1768788775 | K150390 | Nautilus Spinal System | NKB | 2015-03-16 |
| 63214 | 1959030631 | K150368 | Tarsa-Link Wedge Fixation System | HRS | 2015-03-24 |
| 345405 | 1959030631 | K150368 | Tarsa-Link Wedge Fixation System | HRS | 2015-03-24 |
| 63214 | 1717759975 | K150229 | SOLSTICE OCT System | KWP | 2015-04-07 |
| 345405 | 1717759975 | K150229 | SOLSTICE OCT System | KWP | 2015-04-07 |
| 345405 | 2040377980 | K150126 | Life Spine Cannulated Screws | HWC | 2015-05-11 |
| 63214 | 2013141189 | K143249 | SOLSTICE OCT System | KWP | 2015-04-07 |
| 345405 | 2013141189 | K143249 | SOLSTICE OCT System | KWP | 2015-04-07 |
| 63214 | 1141730898 | K142253 | SOLSTICE OCT System | KWP | 2015-04-23 |
| 345405 | 1141730898 | K142253 | SOLSTICE OCT System | KWP | 2015-04-23 |
| 345405 | 1421261681 | K141905 | PRO-LINK WEDGE SYSTEM | HRS | 2014-09-26 |
| 63214 | 1051423421 | K141246 | LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM | OUR | 2015-02-22 |
| 345405 | 1051423421 | K141246 | LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM | OUR | 2015-02-22 |
| 63214 | 1161332597 | K141222 | NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM | NKB | 2015-02-12 |
| 345405 | 1161332597 | K141222 | NAUTILUS SPINAL SYSTEM AND SOLSTICE OCT SYSTEM | NKB | 2015-02-12 |
| 63214 | 1610498395 | K133717 | LONGBOW SPACER SYSTEM | MAX | 2014-09-19 |
| 345405 | 1610498395 | K133717 | LONGBOW SPACER SYSTEM | MAX | 2014-09-19 |
| 63214 | 1074276225 | K133564 | MODIFICATION TO NAUTILUS SPINAL SYSTEM | NKB | 2014-02-19 |
| 345405 | 1074276225 | K133564 | MODIFICATION TO NAUTILUS SPINAL SYSTEM | NKB | 2014-02-19 |
| 63214 | 1357782801 | K132866 | NAUTILUS SPINAL SYSTEM | NKB | 2013-10-28 |
| 345405 | 1357782801 | K132866 | NAUTILUS SPINAL SYSTEM | NKB | 2013-10-28 |
| 63214 | 1624712114 | K132760 | NAUTILUS SPINAL SYSTEM | NKB | 2013-10-03 |
| 345405 | 1624712114 | K132760 | NAUTILUS SPINAL SYSTEM | NKB | 2013-10-03 |
| 63214 | 1138989203 | K132589 | ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) | KWQ | 2013-10-08 |
| 345405 | 1138989203 | K132589 | ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO) | KWQ | 2013-10-08 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MAX | 43 | 2025-04-09 |
| NKB | 30 | 2023-12-12 |
| KWQ | 21 | 2024-12-11 |
| MNI | 11 | 2012-03-13 |
| KWP | 10 | 2015-04-23 |
| HWC | 8 | 2017-12-14 |
| OUR | 7 | 2024-07-29 |
| OVE | 7 | 2023-10-19 |
| OVD | 7 | 2020-04-17 |
| HRS | 7 | 2017-12-21 |
| ODP | 6 | 2016-12-22 |
| NKG | 5 | 2020-04-28 |
| NQW | 4 | 2019-09-20 |
| JDK | 3 | 2006-07-12 |
| KTT | 2 | 2018-09-07 |
| MNH | 2 | 2006-09-05 |
| OLO | 1 | 2021-08-19 |
| KWD | 1 | 2017-02-01 |
| FMF | 1 | 2015-07-07 |
| MRW | 1 | 2009-06-26 |
| NVR | 1 | 2008-03-17 |
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine, Inc.
Life Spine, Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine, Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine, Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine Inc.
Life Spine
Life Spine Inc.
Life Spine Inc.
Life Spine Inc.
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