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.. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
Recent devices under product code KTT
view allMore clearances from Surgical Instrument Service and Savings, Inc.
view all- K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
- K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
- K243101 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) +1 more
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.