Company ยท US
O'Tec Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1994. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 |
| HTY | Pin, Fixation, Smooth | 3 |
| HWC | Screw, Fixation, Bone | 3 |
| JDR | Staple, Fixation, Bone | 3 |
| JDW | Pin, Fixation, Threaded | 3 |
| IOR | Wheelchair, Mechanical | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 |
| HRS | Plate, Fixation, Bone | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 1994 | K943293 | SCC22/ SCC26 SHOWER COMMODE CHAIR O'Tec Corp. | IOR |
| Jul 1, 1991 | K910093 | FUTURA FEMORAL HIP STEM O'Tec Corp. | JDI |
| Jan 4, 1991 | K905358 | CANCELLOUS SCREW O'Tec Corp. | HWC |
| Jan 4, 1991 | K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) O'Tec Corp. | HWC |
| Jan 4, 1991 | K905355 | BROAD SELF-COMPRESSING PLATE O'Tec Corp. | HRS |
| Jan 4, 1991 | K905347 | HAGIE PIN O'Tec Corp. | JDW |
| Jan 4, 1991 | K905333 | U.S. TYPE CRUCIATE SLOT BONE SCREW O'Tec Corp. | HWC |
| Dec 11, 1990 | K905364 | ROUND STAPLE O'Tec Corp. | JDR |
| Dec 11, 1990 | K905363 | FIXATION STAPLE O'Tec Corp. | JDR |
| Dec 11, 1990 | K905362 | BARBED SQUARE STAPLE O'Tec Corp. | JDR |
| Dec 11, 1990 | K905352 | BLADE PLATE O'Tec Corp. | KTT |
| Dec 11, 1990 | K905349 | AUSTIN MOORE TYPE HIP PROTHESIS O'Tec Corp. | KWL |
| Dec 11, 1990 | K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL O'Tec Corp. | KTW |
| Dec 11, 1990 | K905346 | JEWETT HIP NAIL O'Tec Corp. | KTT |
| Dec 11, 1990 | K905345 | K-WIRE O'Tec Corp. | HTY |
| Dec 11, 1990 | K905344 | KNOWLES PIN O'Tec Corp. | JDW |
| Dec 11, 1990 | K905342 | LAG SCREW O'Tec Corp. | KTT |
| Dec 11, 1990 | K905341 | RUSH PIN O'Tec Corp. | HTY |
| Dec 11, 1990 | K905338 | SIDE PLATE O'Tec Corp. | KTT |
| Dec 11, 1990 | K905337 | STEINMAN PIN O'Tec Corp. | HTY |
| Dec 11, 1990 | K905336 | STEINMAN PIN, THREADED O'Tec Corp. | JDW |
| Dec 11, 1990 | K905334 | THOMPSON TYPE HIP PROSTHESIS O'Tec Corp. | KWL |
| Aug 2, 1988 | K883034 | WHEELCHAIR BCW 6000 O'Tec Corp. | IOR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||