Submission Details
| 510(k) Number | K200613 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 2020 |
| Decision Date | April 15, 2020 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
Tritanium? X TL Expandable Curved Posterior Lumbar Cage
Apr 2020
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K200613 is an FDA 510(k) clearance for the Tritanium? X TL Expandable Curved Posterior Lumbar Cage, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on April 15, 2020, 37 days after receiving the submission on March 9, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.
Device Classification
| Product Code | MAX — Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |
Manufacturer
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