CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER— 510(k) K112383

Substantially Equivalent

Skeletal Kinetics, LLC

FDA 510(k) clearance K112383 for CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER, Substantially Equivalent on 2012-02-07. Applicant: Skeletal Kinetics, LLC.

Clearance details

Applicant: Skeletal Kinetics, LLC
Product code: Code MQV
Advisory panel: Orthopedic
Date received: 2011-08-18
Decision date: 2012-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cupertino, CA, US

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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.