FDA.report

Highridge Medical, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30124476123012447612Highridge Medical, LLC1Y2026-01-0110225 Westmoor Dr Westminster CO US 80021

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1945831977045106P980048
1945831939083492P950002BAK INTERBODY FUSION SYSTEMMAX 1996-09-20
1945831074432338P860005PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLEROIS 1992-10-29
1945831424780603P850035EBI SPF IMPLANTABLE SPINAL FUSION STIMULATORLOE1987-04-30
1945831424780603P850035EBI SPF IMPLANTABLE SPINAL FUSION STIMULATORLOE1987-04-30
1945831765610172P850022ORTHOPAK(R) BONE GROWTH STIMULATORLOF1986-02-18
1945831765610172P850022ORTHOPAK(R) BONE GROWTH STIMULATORLOF1986-02-18
1945831308850975P790005OSTEOSTIM(R)LOE1980-01-25
1945831277830725P790002BIO OSTEOGEN SYSTEM 204LOF1979-11-06
1945831277830725P790002BIO OSTEOGEN SYSTEM 204LOF1979-11-06
1945831023751223P120024ACTIVL ARTIFICIAL DISCMJO2015-06-11
1945831417523004K993067SILHOUETTE SPINAL FIXATION SYSTEMKWP1999-11-16
1945831702443651K992276MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEMMNI1999-10-01
1945831701654297K992147TRIPLE-FIX SPINAL FIXATION SYSTEMMNI2000-02-28
1945831091100765K991794ENDOSCOPIC SPINAL ACCESS SYSTEMHRX1999-08-13
1945831374685692K990131PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTEMQV1999-03-02
1945831912312855K990005SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMKWQ1999-02-12
1945831176832334K984578SYNERGY D2 SPINAL IMPLANTSMNI1999-03-23
1945831314347195K983144FLEXPOSURE RETRACTORHRX1999-02-24
1945831476353441K982819ENDIUS SPINE ENDOSCOPEGWG1999-01-27
1945831123657335K980817PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30LMQV1998-09-25
1945831107763706K980288SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEMKWP1998-07-29
1945831998627308K974435MICHELSON ANTERIOR CERVICAL PLATE SYSTEMKWQ1998-02-19
1945831494283518K974020SPINAL CONCEPTS, INC., CFIX CABLE SYSTEMJDQ1997-12-19
1945831782335381K973836SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEMMNH1998-03-05
1945832001522687K973687SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEMMNH1998-03-18
1945831544864108K973586SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM IIHWC1997-11-07
1945831122602658K964404BACFIX SPINAL FIXATION SYSTEMKWP1997-03-26
1945831498688014K950709SYNERGY TI ANTERIOR SPINAL SYSTEMKWQ1995-10-25
1945831794678300K950165INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONSLYC1995-03-28
1945831692387298K950099SYNERGY(TM) TI POSTERIOR SPINAL SYSTEMMNH1997-01-16
1945831090843380K931653SPINE-TECH CERVICAL FIXATION SYSTEMKWQ1994-08-04
1945831592246785K860983INTERPORE 200 POROUS HYDROXYAPATITELYC1986-05-23
1945831680177307K811820BIPOLAR COAGULATING FORCEPSGEI1981-07-28
1945831082967043K250332Virage® OCT Spinal Fixation SystemNKG2025-04-04
1945831378741094K243116FlareHawk Interbody Fusion SystemMAX2025-05-21
1945831517083955K240647Virage® Navigation SystemOLO2024-04-05
1945831352208303K240539Vital™ Spinal Fixation SystemNKB2024-03-15
1945831155700157K233443Vital™ Navigation SystemOLO2023-11-16
1945831864651855K231769activL® Next Generation InstrumentationQLQ2023-07-13
1945831869749365K231098LineSider® Spinal SystemNKB2023-08-07
1945831159258644K230116Vital™ Spinal Fixation SystemNKB2023-10-11
1945831585179199K220453FlareHawk Interbody Fusion SystemMAX2022-03-24
1945831204129087K213720Vital Navigation SystemOLO2022-01-07
1945831026152446K213355Toro-L Interbody Fusion SystemMAX2022-03-25
1945831274731820K212088Integrity Implants Navigated InstrumentsOLO2021-12-23
1945832010964753K212023Virage Navigation SystemOLO2021-08-27
1945831593970455K210275Polaris Spinal SystemNKB2021-04-02
1945831269215369K203507Vitality® Spinal Fixation SystemNKB2021-01-28
1945831152791057K203367LineSider™ Spinal SystemNKB2020-12-03
1945831491903510K203038Toro-L Interbody Fusion SystemMAX2021-03-26
1945831164636805K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion SystemKWQ2020-10-08
1945831051912726K202198FlareHawk Interbody Fusion SystemMAX2020-11-03
1945831853481058K201367FlareHawk TiHawk9 Interbody Fusion SystemMAX2020-09-23
1945831300662100K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemOVD2020-04-28
1945831239931345K192133Zimmer Biomet Universal Navigation SystemOLO2019-10-29
1945831059471362K191722Vital Navigation SystemOLO2019-12-02
1945831889061859K190556Zimmer Biomet Universal Navigation SystemOLO2019-10-24
1945831084954105K190360LineSider™ Spinal SystemNKB2019-06-21
1945831788356686K183550Vitality® Spinal Fixation SystemNKB2019-04-08
1945831923221613K183184FlareHawk Interbody Fusion SystemMAX2019-04-03
1945831392101921K182114FlareHawk Interbody Fusion SystemMAX2019-01-07
1945831399151674K180227Polaris Spinal Growth SystemPGM2018-03-15
1945831607977396K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemNKB2017-09-27
1945831376430977K171907Vitality® Spinal Fixation SystemNKB2017-07-14
1945831007751102K171495Zyston Strut Open Titanium Spacer SystemMAX2018-02-12
1945831084265617K170676HD Lumbar Interbody SystemMAX2017-07-13
1945831009272735K163543Biomet Fusion SystemOVD2017-02-28
1945831823605435K162133VerteFIT Corpectomy Cage SystemMQP2017-05-16
1945831889958239K161798FacetBRIDGE® SystemMRW2016-08-04
1945831889958239K161798FacetBRIDGE® SystemMRW2016-08-04
1945831216656934K161173Avenue® T TLIF CageOVD2016-09-28
1945831216656934K161173Avenue® T TLIF CageOVD2016-09-28
1945831135835773K160076XCage™ Interbody Fusion SystemMAX2016-10-13
1945832034950760K153695Biomet Spine Fusion SystemMAX2016-01-21
1945831487649277K153631Zimmer Virage OCT Spinal Fixation SystemNKG2016-02-16
1945831654880553K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemMAX2016-03-31
1945831654880553K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemMAX2016-03-31
1945831415674864K152137FacetBRIDGE SystemMRW2016-01-25
1945831415674864K152137FacetBRIDGE SystemMRW2016-01-25
1945831642904503K151974Polaris Spinal SystemNKB2015-11-13
1945831686486019K151934ROI-C Titanium-Coated Implant SystemOVE2015-12-07
1945831686486019K151934ROI-C Titanium-Coated Implant SystemOVE2015-12-07
1945831727862257K151224Lineum OCT Spine SystemNKG2015-06-30
1945832024992708K151031Virage OCT Spinal Fixation SystemNKG2015-06-24
1945831085102177K150896Vitality Spinal Fixation SystemNKB2015-08-31
1945831502050169K150765LDR Spine ROI-C Cervical Cage SystemOVE2015-09-17
1945831502050169K150765LDR Spine ROI-C Cervical Cage SystemOVE2015-09-17
1945831398463832K143626inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation SystemKWQ2015-03-20
1945831628369572K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)MAX2015-02-12
1945831818931604K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal SystemNKB2015-06-18
1945832062376770K142053UNIVERSAL CLAMP SPINAL FIXATION SYSTEMOWI2014-10-29
1945831623329693K141804POLARIS SPINAL SYSTEM - HA COATEDNKB2014-09-25
1945831231553498K141791BIOMET FUSION SYSTEMOVD2014-10-09
1945831189699581K141500OPTIO-C ANTERIOR CERVICAL SYSTEMKWQ2014-09-23
1945831706454249K140734NEXTGEN ALTIUS OCT SYSTEMKWP2014-12-15
1945831020672628K140611TRINICA ANTERIOR LUMBAR PLATE SYSTEMKWQ2014-05-21
1945831217928134K140123POLARIS SPINAL SYSTEM -TRANSLATION SCREWNKB2014-04-24
1945832071892817K133784VISTA-S DEVICE, ASSOCIATED INSTRUMENTATIONODP2014-07-07
1945831332764081K133746POLARIS SPINAL SYSTEMNKB2014-03-12
1945831962568282K133556VIRAGE OCT SPINAL FIXATION SYSTEMKWP2014-06-02
1945831571894436K133518MAXAN ANTERIOR CERVICAL PLATE SYSTEMKWQ2014-11-05
1945831691748344K133514XCAGE INTERBODY FUSION SYSTEMMAX2014-05-01
1945831723529982K133363INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEMPEK2014-03-07
1945831723529982K133363INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEMPEK2014-03-07
1945831715676889K133291ST360 DEGREES SPINAL FIXATION SYSTEMNKB2013-12-17
1945831862277629K133184ARDIS INTERBODY SYSTEMMAX2014-01-30
1945831610000950K133086TITLE 2 POLYAXIAL SPINAL SYSTEMNKB2013-11-27
1945831884213339K132894OPTIO-C ANTERIOR CERVICAL SYSTEMOVE2014-01-16
1945831446766716K132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMNKB2013-11-25
1945831015644518K132790INFIX ANTERIOR LUMBAR SYSTEMMAX2013-12-20
1945831479474365K132012TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEMKWQ2013-08-29
1945831419618037K131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEMNKB2013-09-04
1945831628668270K131615POLARIS SPINAL SYSTEMOSH2013-09-04
1945831998922405K131547LANX FUSION SYSTEMOVD2013-07-12
1945831326374116K131242ARDIS INTERBODY SYSTEMMAX2013-09-03
1945831776584827K131156LANX SPINAL FIXATION SYSTEMKWP2013-05-24
1945831788356704K123767LANX FUSION SYSTEM- SAOVD2013-03-18
1945831089819948K123602TM ARDIS INTERBODY SYSTEM INSERTERMAX2013-03-01
1945831614736974K123549POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMNKB2013-02-25

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NKB652024-03-15
MAX362025-05-21
KWQ362020-10-08
KWP342014-12-15
MNI222010-10-15
MQP192017-05-16
OVD142020-04-28
MNH112012-06-27
ODP92014-07-07
OLO82024-04-05
OVE72015-12-07
MQV62009-04-02
MRW52016-08-04
NKG42025-04-04
HRX42006-06-06
LOF41986-02-18
JDQ32008-08-29
LOE31987-04-30
PEK22014-03-07
LYC21995-03-28
QLQ12023-07-13
PGM12018-03-15
MJO12015-06-11
OWI12014-10-29
OSH12013-09-04
NQP12010-08-18
NQW12010-07-20
FST12008-02-22
KNW12005-11-07
GZT12005-04-15
GWG11999-01-27
HWC11997-11-07
MAX 11996-09-20
OIS 11992-10-29
GEI11981-07-28

PMA

PMN

Applications

GUDID