Fuse Cage
FDA 510(k) K121288 · Advanced Medical Technologies AG
510(k) numberK121288
Submission
- Device name
- Fuse Cage
- Applicant
- Advanced Medical Technologies AG
Nonnweiler-Braunshausen, DE - Received
- April 30, 2012
- Decision date
- June 29, 2012
- 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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| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121333 | Wave D CageMAX · Traditional | 06/29/2012SE |
| K121332 | Loop CageMAX · Traditional | 06/29/2012SE |
| K121330 | Wave O CageMAX · Traditional | 06/29/2012SE |
| K103573 | ARTS2 Spinal Fixation SystemMNH · Traditional | 12/28/2011SE |
| K100945 | Fuse Plif CafeMAX · Traditional | 02/09/2011SE |
| K080401 | Shell Cage, Wave Cage, Loop CageMAX · Traditional | 05/09/2008SE |
| K053473 | Maestro MDTL Laser SystemILY · Traditional | 02/03/2006SE |
| K043353 | Omega Excel/Xp Laser SystemNHN · Traditional | 07/01/2005SE |
| K033148 | Art Anterior Spinal SystemKWQ · Traditional | 04/12/2004SE |
| K033150 | Art Posterior Spinal SystemMNI · Traditional | 03/01/2004SE |
Questions and answers
When was Fuse Cage cleared by the FDA?
Fuse Cage (K121288) received a 510(k) decision of Substantially Equivalent on June 29, 2012, 60 days after the submission was received.
What is the product code of K121288?
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.