The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Brightmatter Guide With Surface Trace Registration.
| Device ID | K153281 |
| 510k Number | K153281 |
| Device Name: | BrightMatter Guide With Surface Trace Registration |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g1l7 |
| Contact | Cameron Piron |
| Correspondent | Cameron Piron SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g1l7 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00670082000375 | K153281 | 000 |
| 00670082000191 | K153281 | 000 |
| 00670082000078 | K153281 | 000 |
| 00670082000061 | K153281 | 000 |
| 00670082000054 | K153281 | 000 |
| 00670082000047 | K153281 | 000 |
| 00670082000030 | K153281 | 000 |
| 00670082000023 | K153281 | 000 |
| 00670082000016 | K153281 | 000 |