CALIX LUMBAR SPINAL IMPLANT SYSTEM— 510(k) K131350
Substantially EquivalentX-Spine Systems, Inc.
FDA 510(k) clearance K131350 for CALIX LUMBAR SPINAL IMPLANT SYSTEM, Substantially Equivalent on 2013-10-23. Applicant: X-Spine Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- X-Spine Systems, Inc.
- Product code
- Code MAX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miamisburg, OH, US
Recent devices under product code MAX
view allMore clearances from X-Spine Systems, Inc.
view allAdverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K131350
K-number listed on FDA's recall record- Z-0124-2017 — Calix P PEEK Lumbar System, PLIF Rasp
- Z-0125-2017 — Calix P PEEK Lumbar System, PLIF Trial
- Z-0126-2017 — Calix T PEEK Lumbar System, TLIF Rasp
- Z-0127-2017 — Calix T PEEK Lumbar System, TLIF Trial
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131350.
Data sourced from openFDA. This site is unofficial and independent of the FDA.