aprevo® cervical plating system— 510(k) K252611
Substantially EquivalentCarlsmed, Inc.
FDA 510(k) clearance K252611 for aprevo® cervical plating system, Substantially Equivalent on 2025-12-22. Applicant: Carlsmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Carlsmed, Inc.
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code KWQ
view allMore clearances from Carlsmed, Inc.
view all- K260385 — aprevo® anterior and lateral lumbar interbody system +3 more
- K252894 — aprevo® cervical interbody system
- K250827 — aprevo® anterior lumbar interbody fusion device +7 more
- K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device
- K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.