BEE PLIF Cage
FDA 510(k) K211413 · NGMedical GmbH
510(k) numberK211413
Submission
- Device name
- BEE PLIF Cage
- Applicant
- NGMedical GmbH
Nonnweiler, DE - Received
- May 6, 2021
- Decision date
- August 27, 2021
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K261067 | BEE PLIF CageMAX · Special | 04/30/2026SE |
| K250560 | Bee HaODP · Traditional | 11/21/2025SE |
| K231371 | BEE Cervical CageODP · Traditional | 01/12/2024SE |
| K212050 | NGM WAVE PLIF CageMAX · Traditional | 12/01/2021SE |
| K203444 | BEE HA CageODP · Traditional | 03/18/2021SE |
| K200429 | BEE CagesODP · Traditional | 01/29/2021SE |
Questions and answers
When was BEE PLIF Cage cleared by the FDA?
BEE PLIF Cage (K211413) received a 510(k) decision of Substantially Equivalent on August 27, 2021, 113 days after the submission was received.
What is the product code of K211413?
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.