The following data is part of a premarket notification filed by Creative Medical Designs, Inc. with the FDA for Rayhack Low Profile Locking Plate And Instruments.
| Device ID | K061955 |
| 510k Number | K061955 |
| Device Name: | RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS |
| Classification | Plate, Fixation, Bone |
| Applicant | CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa, FL 33613 |
| Contact | Jane Rayhack |
| Correspondent | Jane Rayhack CREATIVE MEDICAL DESIGNS, INC. 13914 SHADY SHORES DR. Tampa, FL 33613 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-11 |
| Decision Date | 2006-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420143785 | K061955 | 000 |
| 00840420143587 | K061955 | 000 |
| 00840420143570 | K061955 | 000 |
| 00840420143563 | K061955 | 000 |
| 00840420143556 | K061955 | 000 |
| 00840420143549 | K061955 | 000 |
| 00840420143532 | K061955 | 000 |
| 00840420143525 | K061955 | 000 |
| 00840420143518 | K061955 | 000 |
| 00840420143501 | K061955 | 000 |
| 00840420143495 | K061955 | 000 |
| 00840420143488 | K061955 | 000 |
| 00840420143471 | K061955 | 000 |
| 00840420143464 | K061955 | 000 |
| 00840420143457 | K061955 | 000 |
| 00840420143440 | K061955 | 000 |
| 00840420143433 | K061955 | 000 |
| 00840420143594 | K061955 | 000 |
| 00840420143600 | K061955 | 000 |
| 00840420143617 | K061955 | 000 |
| 00840420143778 | K061955 | 000 |
| 00840420143761 | K061955 | 000 |
| 00840420143754 | K061955 | 000 |
| 00840420143747 | K061955 | 000 |
| 00840420143730 | K061955 | 000 |
| 00840420143723 | K061955 | 000 |
| 00840420143716 | K061955 | 000 |
| 00840420143709 | K061955 | 000 |
| 00840420143693 | K061955 | 000 |
| 00840420143686 | K061955 | 000 |
| 00840420143679 | K061955 | 000 |
| 00840420143662 | K061955 | 000 |
| 00840420143655 | K061955 | 000 |
| 00840420143648 | K061955 | 000 |
| 00840420143631 | K061955 | 000 |
| 00840420143624 | K061955 | 000 |
| 00840420143419 | K061955 | 000 |