The following data is part of a premarket notification filed by Blackstone Medical, Inc. with the FDA for Blakstone Laminoplasty Fixation System.
| Device ID | K043338 |
| 510k Number | K043338 |
| Device Name: | BLAKSTONE LAMINOPLASTY FIXATION SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Contact | Dean Ciporkin |
| Correspondent | Dean Ciporkin BLACKSTONE MEDICAL, INC. 90 BROOKSDALE DR. Springfield, MA 01104 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-03 |
| Decision Date | 2005-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18257200081110 | K043338 | 000 |
| 18257200031702 | K043338 | 000 |
| 18257200031849 | K043338 | 000 |
| 18257200031856 | K043338 | 000 |
| 18257200031863 | K043338 | 000 |
| 18257200031870 | K043338 | 000 |
| 18257200031887 | K043338 | 000 |
| 18257200031894 | K043338 | 000 |
| 18257200031900 | K043338 | 000 |
| 18257200031917 | K043338 | 000 |
| 18257200031924 | K043338 | 000 |
| 18257200031931 | K043338 | 000 |
| 18257200031696 | K043338 | 000 |