The following data is part of a premarket notification filed by Musculoskeletal Clinical Regulatory Advisers with the FDA for Vu Cpod Intervertebral Bodu Fusion Device.
| Device ID | K101363 |
| 510k Number | K101363 |
| Device Name: | VU CPOD INTERVERTEBRAL BODU FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Contact | Glenn Stiegman |
| Correspondent | Glenn Stiegman MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2010-12-16 |
| Summary: | summary |