4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
FDA 510(k) K190563 · Solco Biomedical Co., Ltd.
510(k) numberK190563
Submission
- Device name
- 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
- Applicant
- Solco Biomedical Co., Ltd.
Pyeongtaek, KR - Received
- March 5, 2019
- Decision date
- September 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code MAX
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation SystemNKB · Special | 11/26/2024SE |
| K203233 | 4CIS Chiron Spinal Fixation SystemNKB · Special | 06/01/2022SE |
| K192044 | 4CIS Marlin PEEK ACIF CageODP · Traditional | 12/19/2019SE |
| K190471 | 4CIS® Chiron Spinal Fixation SystemNKB · Traditional | 07/24/2019SE |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate systemKWQ · Traditional | 01/16/2019SE |
| K162402 | 4CIS® Marlin ACIF Cage SystemODP · Traditional | 02/16/2017SE |
| K121615 | 4CIS Vane Spine SystemMNI · Special | 08/15/2012SE |
| K102458 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemMNH · Special | 06/13/2011SE |
| K101818 | 4CIS Vane Spine SystemMNH · Traditional | 02/11/2011SE |
| K092162 | 4CIS PEEK, Plif and Tlif Cage SystemMAX · Traditional | 01/06/2010SE |
Questions and answers
When was 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage cleared by the FDA?
4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage (K190563) received a 510(k) decision of Substantially Equivalent on September 18, 2019, 197 days after the submission was received.
What is the product code of K190563?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.