The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Hallmark Anterior Cervcial Plate System, Hallmark Five-level Cervical Plates.
| Device ID | K100614 |
| 510k Number | K100614 |
| Device Name: | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470 |
| Contact | Darla Chew |
| Correspondent | Darla Chew BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 Wayne, NJ 07470 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-04 |
| Decision Date | 2010-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200081523 | K100614 | 000 |
| 18257200018345 | K100614 | 000 |
| 18257200018338 | K100614 | 000 |
| 18257200018321 | K100614 | 000 |
| 18257200018314 | K100614 | 000 |
| 18257200018307 | K100614 | 000 |
| 18257200018291 | K100614 | 000 |
| 18257200018284 | K100614 | 000 |
| 18257200018277 | K100614 | 000 |
| 18257200018260 | K100614 | 000 |
| 18257200018253 | K100614 | 000 |
| 18257200018246 | K100614 | 000 |
| 18257200018352 | K100614 | 000 |
| 18257200018369 | K100614 | 000 |
| 18257200081516 | K100614 | 000 |
| 18257200018468 | K100614 | 000 |
| 18257200018451 | K100614 | 000 |
| 18257200018444 | K100614 | 000 |
| 18257200018437 | K100614 | 000 |
| 18257200018420 | K100614 | 000 |
| 18257200018413 | K100614 | 000 |
| 18257200018406 | K100614 | 000 |
| 18257200018390 | K100614 | 000 |
| 18257200018383 | K100614 | 000 |
| 18257200018376 | K100614 | 000 |
| 18257200018239 | K100614 | 000 |