Neosteo
Round Rock, TX, US
Neosteo appears in FDA device records in Round Rock, TX. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Neosteo between 2013 and 2022. The busiest year on record is 2015, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212545 | FlexitSystem Knee osteotomy system | HRS | Substantially Equivalent | |
| K192447 | Superelastic Staple | JDR | Substantially Equivalent | |
| K191424 | Interphalangeal Joint Fusion Device Range | HWC | Substantially Equivalent | |
| K153182 | SELF- COMPRESSIVE SCREW | HWC | Substantially Equivalent | |
| K150772 | Snap-Off Self-Compressive Screw | HWC | Substantially Equivalent | |
| K131471 | SELF-COMPRESSIVE SCREW | HWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2236-2021 | Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery. | Traces of corrosion on the laser marking was detected on cannulated graduated drill bit, which could lead to the emission of wear / corrosion particles in the operated area, potentially leading to the following risks: Inflammation, pain, allergy, adverse tissue reaction. Device description: The drill bit is used to create the hole required for the introduction of the screw, it is suitable for Neosteo compression screws for cortical and spongy bone. Drilling depth can be read on the instrument. The shaft is coupled with the 4.5mm surgical motor using a AO 4.5mm male drive connexion. The countersink bit is coupled to a 1.0mm k-wire to ensure guiding while drilling. The instrument is packaged in a plastic sheath sealed by welding. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain