The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Aesculap Peek Intervertebral Body Fusion System: A Space, Cespace, Prospace, T-space.
| Device ID | K071983 |
| 510k Number | K071983 |
| Device Name: | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. 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 | 2007-07-19 |
| Decision Date | 2008-05-01 |
| Summary: | summary |