UNiD IB3D ALIF
FDA 510(k) K200316 · Medicrea International SA
510(k) numberK200316
Submission
- Device name
- UNiD IB3D ALIF
- Applicant
- Medicrea International SA
Rillieux-La-Pape, FR - Received
- February 7, 2020
- Decision date
- October 30, 2020
- 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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| K213281 | PASS LP Spinal System, CD Horizon Spinal SystemNKB · Traditional | 01/05/2022SE |
| K210470 | C-CURVE Interbody Fusion DeviceOVE · Traditional | 09/03/2021SE |
| K191134 | IB3D AlifMAX · Traditional | 10/30/2019SE |
| K182158 | UNiD Patient-matched PLIF cageMAX · Traditional | 07/15/2019SE |
| K190092 | UNiD Patient specific 3D printed TLIF cageMAX · Traditional | 05/08/2019SE |
| K190376 | PASS LP Spinal SystemNKB · Traditional | 05/02/2019SE |
Questions and answers
When was UNiD IB3D ALIF cleared by the FDA?
UNiD IB3D ALIF (K200316) received a 510(k) decision of Substantially Equivalent on October 30, 2020, 266 days after the submission was received.
What is the product code of K200316?
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.