Medline ReNewal Reprocessed Synthes External Fixation Systems— 510(k) K171911
Substantially EquivalentSurgical Instrument Service and Savings, Inc.
FDA 510(k) clearance K171911 for Medline ReNewal Reprocessed Synthes External Fixation Systems, Substantially Equivalent on 2017-11-09. Applicant: Surgical Instrument Service and Savings, Inc..
Clearance details
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Product code
- Code KTT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.