Integra Radionics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Integra Radionics, Inc.” (first 2006, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 4 | 4 |
| MUJ | System, Planning, Radiation Therapy Treatment | 4 | 4 |
| IYE | Accelerator, Linear, Medical | 2 | 2 |
Review panels
Most recent Integra Radionics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102258 | CUSA NXT EXTENDED LENGTH TIP | LFL | 2011-06-10 | 304 |
| K100096 | LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART | IYE | 2010-04-22 | 99 |
| K100417 | XKNIFE 5 | MUJ | 2010-04-08 | 51 |
| K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 2009-05-08 | 39 |
| K083414 | RADIONICS XKNIFE HDRT SYSTEM | MUJ | 2009-03-02 | 104 |
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | LFL | 2008-08-13 | 82 |
| K072454 | INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS | IYE | 2007-10-16 | 46 |
| K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP | LFL | 2007-08-17 | 59 |
| K063230 | INTEGRA RADIONICS IMAGEFUSION 3 | MUJ | 2006-12-21 | 57 |
| K061893 | INTEGRA RADIONICS XKNIFE RT 4 | MUJ | 2006-07-25 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Integra Radionics, Inc..
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.
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.
- Integra LifeSciences Corporation (94 510(k)s)
- Integra Neurocare, LLC (12 510(k)s)
- Integra Lifesciences Production Corporation (9 510(k)s)
- Integra Neurosciences (9 510(k)s)
- Integra Neurosciences Implants S.A. (6 510(k)s)
- Integra Life Sciences (3 510(k)s)
- Integra Lifescience Corportation (2 510(k)s)
- Integra Medical (2 510(k)s)
- Integra Biotechnical, LLC (1 510(k)s)
- Integra Burlington Ma, Inc. (1 510(k)s)
- Integra Burlington Ma, Inc. (Formerly Integra Radi (1 510(k)s)
- Integra Lifesciences Corporation (Owner of Tei Biosciences) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Integra Radionics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Integra Radionics, Inc.” (first 2006, latest 2011), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Integra Radionics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Integra Radionics, Inc. is 58 days.
Which FDA product codes appear under Integra Radionics, Inc.?
The most frequent FDA product codes under this applicant name are LFL (Instrument, Ultrasonic Surgical, 4); MUJ (System, Planning, Radiation Therapy Treatment, 4); IYE (Accelerator, Linear, Medical, 2).
Next steps
- See all 10 Integra Radionics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LFL, Integra Radionics, Inc.'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.