510(k) K131425 ยท OLO Orthopedic Stereotaxic Instrument
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
| Applicant | Medtronic Navigation, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 14, 2013 |
| Received | May 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2025 | Medtronic Navigation, Inc. Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235
Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236
The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove Open, Classified |
OLO | None listed |
| Jan 10, 2024 | Medtronic Navigation, Inc. Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Open, Classified |
OLO | None listed |
| Jan 10, 2024 | Medtronic Navigation, Inc. Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Open, Classified |
OLO | None listed |
| Dec 6, 2018 | Medtronic Navigation, Inc. Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 0064 Terminated |
OLO | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attach Terminated |
OLO | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attac Terminated |
OLO | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid Terminated |
OLO | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Double Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigi Terminated |
OLO | None listed |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intende Terminated |
OLO | None listed |
| Jul 18, 2016 | Medtronic Navigation, Inc. Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid for pr Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.