510(k) K232792
- Device
- icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn? TLIF Lumbar Cage)
- Applicant
- Icotec AG
- 510(k) number
- K232792
- Product code
- MAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-05
- Date received
- 2023-09-11
- 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
- Marina Hess
- Address
- Industriestrasse 12 9450 Altstaetten (Sg) CH
FDA Registration Numbers#
- 3014937101
- 3009051471
- 3004499989
- 3010197239
- 1526534
- 3010197224
- 3013921069
- 9681465
- 3005641619
- 3010120339
- 3007024186
- 2183449
- 9611390
- 2032093
- 3004635447
- 2532027
- 3015216945
- 3008114965
- 3010160527
- 3010560653
- 3012429289
- 3005827567
- 3005751028
- 3004941535
- 1054811
- 3010866843
- 3010175289
- 3017528621
- 9617297
- 2530808
- 3019837678
- 1226146
- 3010329663
- 3011301313
- 3011181154
- 3007303113
- 3013413393
- 1828288
- 3012966183
- 3010123206
- 3009882462
- 3009144915
- 3004142400
- 3013820501
- 3023852420
- 3010120148
- 1030489
- 3010173425
- 3009971621
- 3019356409
- 3017565094
- 9615766
- 1319660
- 3010326971
- 3013422238
- 3009887475
- 3006563559
- 3010120104
- 3005325790
- 3021559833
- 3023138345
- 3015255331
- 3009756327
- 3010375065
- 3006846753
- 1420032
- 3009959868
- 1935627
- 3010162973
- 1530530
- 1834331
- 3036756245
- 3010057495
- 3002807561
- 3008110533
- 3010462278
- 1833824
- 3039167712
- 1528646
- 2133928
Source Documents#
Other 510(k) Records For Product Code MAX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261159 | Exceed® Biplanar Expandable Interbody System | Spine Wave, Inc. | 2026-05-29 |
| K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026-05-28 |
| 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 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | 2026-01-08 |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | 2025-12-19 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | 2025-11-25 |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | 2025-10-28 |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025-10-24 |