O'Tec Corp.
Memphis, TN, US
O'Tec Corp. appears in FDA device records in Memphis, TN. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for O'Tec Corp. between 1990 and 1991. The busiest year on record is 1990, with 15. The most recent is 1991, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 15 |
| 1991 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K910093 | FUTURA FEMORAL HIP STEM | JDI | Substantially Equivalent | |
| K905358 | CANCELLOUS SCREW | HWC | Substantially Equivalent for Some Indications | |
| K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) | HWC | Substantially Equivalent for Some Indications | |
| K905355 | BROAD SELF-COMPRESSING PLATE | HRS | Substantially Equivalent for Some Indications | |
| K905347 | HAGIE PIN | JDW | Substantially Equivalent for Some Indications | |
| K905333 | U.S. TYPE CRUCIATE SLOT BONE SCREW | HWC | Substantially Equivalent for Some Indications | |
| K905364 | ROUND STAPLE | JDR | Substantially Equivalent | |
| K905363 | FIXATION STAPLE | JDR | Substantially Equivalent | |
| K905362 | BARBED SQUARE STAPLE | JDR | Substantially Equivalent | |
| K905352 | BLADE PLATE | KTT | Substantially Equivalent | |
| K905349 | AUSTIN MOORE TYPE HIP PROTHESIS | KWL | Substantially Equivalent | |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | KTW | Substantially Equivalent | |
| K905346 | JEWETT HIP NAIL | KTT | Substantially Equivalent | |
| K905345 | K-WIRE | HTY | Substantially Equivalent | |
| K905344 | KNOWLES PIN | JDW | Substantially Equivalent | |
| K905342 | LAG SCREW | KTT | Substantially Equivalent | |
| K905341 | RUSH PIN | HTY | Substantially Equivalent | |
| K905338 | SIDE PLATE | KTT | Substantially Equivalent | |
| K905337 | STEINMAN PIN | HTY | Substantially Equivalent | |
| K905336 | STEINMAN PIN, THREADED | JDW | Substantially Equivalent | |
| K905334 | THOMPSON TYPE HIP PROSTHESIS | KWL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
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