The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Aesculap Peek Xp Spinal Implant System.
| Device ID | K132421 |
| 510k Number | K132421 |
| Device Name: | AESCULAP PEEK XP SPINAL IMPLANT SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PWKY. Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP IMPLANT SYSTEMS, INC. 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 | 2013-08-05 |
| Decision Date | 2014-01-22 |
| Summary: | summary |