SurgTech Interbody System
FDA 510(k) K152200 · Surgtech, Inc.
510(k) numberK152200
Submission
- Device name
- SurgTech Interbody System
- Applicant
- Surgtech, Inc.
Westlake, OH, US - Received
- August 6, 2015
- Decision date
- March 25, 2016
- 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.
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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 |
|---|---|---|
| K191192 | SurgTech GENOLL Total Knee SystemJWH · Traditional | 08/01/2019SE |
| K173455 | SurgTech Bipolar Head SystemKWY · Traditional | 06/14/2018SE |
| K162125 | MALUC Total Hip Arthroplasty SystemJDI · Traditional | 05/10/2017SE |
| K163363 | SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemNKB · Traditional | 04/05/2017SE |
| K161894 | SurgTech Trauma SystemHWC · Traditional | 02/21/2017SE |
Questions and answers
When was SurgTech Interbody System cleared by the FDA?
SurgTech Interbody System (K152200) received a 510(k) decision of Substantially Equivalent on March 25, 2016, 232 days after the submission was received.
What is the product code of K152200?
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.