Medline ReNewal Reprocessed Stryker External Fixation Devices— 510(k) K163028
Substantially EquivalentSurgical Instrument Service and Savings, Inc.
FDA 510(k) clearance K163028 for Medline ReNewal Reprocessed Stryker External Fixation Devices, Substantially Equivalent on 2016-12-28. Applicant: Surgical Instrument Service and Savings, Inc.. Device class: 2.
Clearance details
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Product code
- Code JEC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, OR, US
Recent devices under product code JEC
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.