The following data is part of a premarket notification filed by Institute Of Musculoskeletal Science & Education with the FDA for Imse P-tlif.
| Device ID | K130506 |
| 510k Number | K130506 |
| Device Name: | IMSE P-TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION 90 S. NEWTOWN STREET ROAD SUITE 10 Newtown Square, PA 19073 |
| Contact | John Moran |
| Correspondent | John Moran INSTITUTE OF MUSCULOSKELETAL SCIENCE & EDUCATION 90 S. NEWTOWN STREET ROAD SUITE 10 Newtown Square, PA 19073 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-27 |
| Decision Date | 2013-05-13 |
| Summary: | summary |