SmartSPACE Shoulder System— 510(k) K191247

Substantially Equivalent

Techmah Medical, LLC

FDA 510(k) clearance K191247 for SmartSPACE Shoulder System, Substantially Equivalent on 2019-11-15. Applicant: Techmah Medical, LLC.

Clearance details

Applicant: Techmah Medical, LLC
Product code: Code KWS
Advisory panel: Orthopedic
Date received: 2019-05-09
Decision date: 2019-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.