SOLUM IV BONE VOID FILLER— 510(k) K132470

Substantially Equivalent

Spinesmith Partners, Llp

FDA 510(k) clearance K132470 for SOLUM IV BONE VOID FILLER, Substantially Equivalent on 2014-05-21. Applicant: Spinesmith Partners, Llp.

Clearance details

Applicant: Spinesmith Partners, Llp
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2013-08-07
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQV

product code MQV

Death: 6
Injury: 435
Total: 441

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.