Pivot Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pivot Medical” (first 2011, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 86 |
| 2014 | 0 | — |
| 2015 | 1 | 66 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Pivot Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151314 | CinchLock Flex Knotless Suture Anchor | MBI | 2015-07-23 | 66 |
| K131769 | CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM | MBI | 2013-10-07 | 112 |
| K130351 | NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER | MBI | 2013-03-14 | 30 |
| K123651 | CINCHLOCK KNOTLESS SUTURE ANCHOR | MBI | 2013-02-21 | 86 |
| K110473 | NANOTACK SUTURE ANCHOR 1.4MM | MBI | 2011-05-25 | 96 |
Recalls
openFDA lists no recalls under a recalling firm named Pivot Medical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Pivot Medical is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01429805: Balloon Assisted Hip Arthroscopy - Clinical Evaluation of a New Tool for Hip Arthroscopy (Completed, started 2011-09)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Pivot Assist, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pivot Medical?
FDA lists 5 510(k) clearances under the applicant name “Pivot Medical” (first 2011, latest 2015), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pivot Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pivot Medical is 86 days.
Which FDA product codes appear under Pivot Medical?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 5).
Next steps
- See all 5 Pivot Medical clearances with predicates and recalls
- Run predicate analysis for product code MBI, Pivot Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.