The following data is part of a premarket notification filed by Medical Concepts, Inc. with the FDA for Medical Concepts Interbody Fusion System.
| Device ID | K110659 |
| 510k Number | K110659 |
| Device Name: | MEDICAL CONCEPTS INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDICAL CONCEPTS, INC. 11467 HUEBNER RD SUITE #350 San Antonio, TX 78230 |
| Contact | Christopher Canis |
| Correspondent | Christopher Canis MEDICAL CONCEPTS, INC. 11467 HUEBNER RD SUITE #350 San Antonio, TX 78230 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-07 |
| Decision Date | 2011-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B104P092515100 | K110659 | 000 |
| B104CP0350 | K110659 | 000 |
| B104CP0340 | K110659 | 000 |
| B104CP0330 | K110659 | 000 |
| B104CP0320 | K110659 | 000 |
| B104CP0310 | K110659 | 000 |
| B104CP0300 | K110659 | 000 |
| B104CL0370 | K110659 | 000 |
| B104CL0360 | K110659 | 000 |
| B104CL0350 | K110659 | 000 |
| B104CL0340 | K110659 | 000 |
| B104CL0330 | K110659 | 000 |
| B104CL0320 | K110659 | 000 |
| B104CL0310 | K110659 | 000 |
| B104CP0360 | K110659 | 000 |
| B104CP0370 | K110659 | 000 |
| B104P092506000 | K110659 | 000 |
| B104P092515000 | K110659 | 000 |
| B104P092514000 | K110659 | 000 |
| B104P092513100 | K110659 | 000 |
| B104P092513000 | K110659 | 000 |
| B104P092512000 | K110659 | 000 |
| B104P092511100 | K110659 | 000 |
| B104P092511000 | K110659 | 000 |
| B104P092510000 | K110659 | 000 |
| B104P092509100 | K110659 | 000 |
| B104P092509000 | K110659 | 000 |
| B104P092508000 | K110659 | 000 |
| B104P092507100 | K110659 | 000 |
| B104P092507000 | K110659 | 000 |
| B104CL0300 | K110659 | 000 |