The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Aesculap T-space Peek And Xp Spinal System.
| Device ID | K151056 |
| 510k Number | K151056 |
| Device Name: | Aesculap T-Space PEEK And XP Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Lisa M. Boyle |
| Correspondent | Lisa M. Boyle AESCULAP IMPLANT SYSTEMS, LLC 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-08-13 |
| Summary: | summary |