510(k) K182920
- Device
- MiRus™ Lumbar Interbody Fusion System Consisting Of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lu
- Applicant
- MiRus, LLC
- 510(k) number
- K182920
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-13
- Date received
- 2018-10-19
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jordan Bauman
- Address
- 2150 Newmarket Pkwy. Marietta GA US 30067 30067
FDA Registration Numbers#
- 1834379
- 3004142400
- 9612420
- 3015212339
- 3010531060
- 1720929
- 3017565094
- 1000200989
- 3013730328
- 1649379
- 3014019090
- 3005031160
- 3010375065
- 3023752918
- 3013111980
- 3006783837
- 3010173425
- 2027062
- 2032521
- 2031093
- 3012120772
- 3010197239
- 3010370500
- 3012711663
- 3010123256
- 3008526708
- 3014678447
- 3004717358
- 3016460869
- 3010663372
- 3009381600
- 2530808
- 3005180920
- 3014003062
- 1225492
- 2648623
- 3031240334
- 3043543260
- 3007922509
- 3010462278
- 3030412764
- 3010763958
- 3010120326
- 3010049501
- 3009149199
- 3010032903
- 3009129735
- 2531195
- 3010123206
- 3011796723
- 3017521423
- 3031081659
- 8010273
- 3005032068
- 2133928
- 3011648620
- 1835251
- 3007279845
- 3011301313
- 3010560653
- 3014655115
- 3010160527
- 3010705004
- 3007200272
- 2027467
- 3025603301
- 3000170817
- 3009217531
- 9615021
- 3012994232
- 3016438694
- 2135156
- 3036503733
- 3021006165
- 3011127597
- 1221763
- 3042175940
- 3008534770
- 1319660
Source Documents#
Other 510(k) Records For Product Code MAX #
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|---|---|---|---|
| K261430 | TruLift Expandable System | Life Spine, Inc. | 2026-07-28 |
| K253011 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2026-07-17 |
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| K253151 | Fule Interbody Fusion Cage System | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-15 |
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 |
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| K260506 | Ventana® P/T Lumbar Interbody System | Spinal Elements, Inc. | 2026-05-15 |
| K260837 | VersaLift Expandable System | Life Spine, Inc. | 2026-05-12 |
| K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system | Carlsmed, Inc. | 2026-05-09 |
| K261067 | BEE PLIF Cage | NGMedical GmbH | 2026-04-30 |
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | 2026-02-26 |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | 2026-02-23 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026-02-04 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | 2026-01-23 |