The following data is part of a premarket notification filed by Advanced Vertebral Solutions, Llc with the FDA for Advanced Vertebral Solutions Express Bfd.
| Device ID | K100037 |
| 510k Number | K100037 |
| Device Name: | ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ADVANCED VERTEBRAL SOLUTIONS, LLC 124 S. MAPLE STREET Ambler, PA 19002 |
| Contact | Mike Dugery |
| Correspondent | Mike Dugery ADVANCED VERTEBRAL SOLUTIONS, LLC 124 S. MAPLE STREET Ambler, PA 19002 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-06 |
| Decision Date | 2010-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B043AV6173000 | K100037 | 000 |
| B043AV4TI15250C0 | K100037 | 000 |
| B043AV4TI13250C0 | K100037 | 000 |
| B043AV4TI12250C0 | K100037 | 000 |
| B043AV4TI11250C0 | K100037 | 000 |
| B043AV4TI10250C0 | K100037 | 000 |
| B043AV4TI09250C0 | K100037 | 000 |
| B043AV4TI08250C0 | K100037 | 000 |
| B043AV417250C0 | K100037 | 000 |
| B043AV415250C0 | K100037 | 000 |
| B043AV413250C0 | K100037 | 000 |
| B043AV412250C0 | K100037 | 000 |
| B043AV411250C0 | K100037 | 000 |
| B043AV410250C0 | K100037 | 000 |
| B043AV409250C0 | K100037 | 000 |
| B043AV4TI17250C0 | K100037 | 000 |
| B043AV6082500 | K100037 | 000 |
| B043AV6172500 | K100037 | 000 |
| B043AV6153000 | K100037 | 000 |
| B043AV6152500 | K100037 | 000 |
| B043AV6133000 | K100037 | 000 |
| B043AV6132500 | K100037 | 000 |
| B043AV6123000 | K100037 | 000 |
| B043AV6122500 | K100037 | 000 |
| B043AV6113000 | K100037 | 000 |
| B043AV6112500 | K100037 | 000 |
| B043AV6103000 | K100037 | 000 |
| B043AV6102500 | K100037 | 000 |
| B043AV6093000 | K100037 | 000 |
| B043AV6092500 | K100037 | 000 |
| B043AV6083000 | K100037 | 000 |
| B043AV408250C0 | K100037 | 000 |