The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Skyhawk Lateral Plate System.
| Device ID | K140260 |
| 510k Number | K140260 |
| Device Name: | SKYHAWK LATERAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Contact | Troy Brooks |
| Correspondent | Troy Brooks ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville, TX 75056 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-03 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200087822 | K140260 | 000 |
| 18257200087686 | K140260 | 000 |
| 18257200087679 | K140260 | 000 |
| 18257200087662 | K140260 | 000 |
| 18257200087655 | K140260 | 000 |
| 18257200087648 | K140260 | 000 |
| 18257200087631 | K140260 | 000 |
| 18257200087624 | K140260 | 000 |
| 18257200087617 | K140260 | 000 |
| 18257200087600 | K140260 | 000 |
| 18257200085354 | K140260 | 000 |
| 18257200087693 | K140260 | 000 |
| 18257200087709 | K140260 | 000 |
| 18257200087716 | K140260 | 000 |
| 18257200087815 | K140260 | 000 |
| 18257200087808 | K140260 | 000 |
| 18257200087792 | K140260 | 000 |
| 18257200087785 | K140260 | 000 |
| 18257200087778 | K140260 | 000 |
| 18257200087761 | K140260 | 000 |
| 18257200087754 | K140260 | 000 |
| 18257200087747 | K140260 | 000 |
| 18257200087730 | K140260 | 000 |
| 18257200087723 | K140260 | 000 |
| 18257200082926 | K140260 | 000 |