Bonutti Research, Inc.
Effingham, IL, US
Bonutti Research, Inc. appears in FDA device records in Effingham, IL. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Bonutti Research, Inc. between 1997 and 2016. The busiest year on record is 1997, with 4. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 4 |
| 1999 | 2 |
| 2001 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K161628 | JAS Pulse(TM) Ultrasonic Therapy | IMI | Substantially Equivalent | |
| K093078 | UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS | HWC | Substantially Equivalent | |
| K090175 | UNITY BETA PLLA SYSTEM | HWC | Substantially Equivalent | |
| K082906 | UNITY BETA ANCHOR SYSTEM | HWC | Substantially Equivalent | |
| K062820 | UNITY ALPHA SYSTEM | HWC | Substantially Equivalent | |
| K060283 | TRANSET SYSTEM | HTY | Substantially Equivalent | |
| K052799 | MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM | MAI | Substantially Equivalent | |
| K033717 | TRANSET FRACTURE FIXATION SYSTEM | HTY | Substantially Equivalent | |
| K013177 | MULTITAK SUTURE SNAP SYSTEM | GAM | Substantially Equivalent | |
| K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR | MAI | Substantially Equivalent | |
| K010479 | MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR | HTY | Substantially Equivalent | |
| K993115 | MULTITAK SS | MAI | Substantially Equivalent | |
| K990156 | MULTITAK SS BUTTONS | MBI | Substantially Equivalent | |
| K973015 | MULTITAK SS SUTURE SYSTEM | MBI | Substantially Equivalent | |
| K971144 | MULTITAK SS SUTURE SYSTEM | MBI | Substantially Equivalent | |
| K964532 | MULTITAK SS SUTURE SYSTEM | MBI | Substantially Equivalent | |
| K964324 | MULTITAK SS SUTURE SYSTEM | MBI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain