The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Interform Interbody Cage System.
| Device ID | K131082 |
| 510k Number | K131082 |
| Device Name: | INTERFORM INTERBODY CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NEXT ORTHOSURGICAL 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb NEXT ORTHOSURGICAL 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-18 |
| Decision Date | 2013-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840314134561 | K131082 | 000 |
| 00840314100443 | K131082 | 000 |
| 00840314100429 | K131082 | 000 |
| 00840314101389 | K131082 | 000 |
| 00840314102829 | K131082 | 000 |
| 00840314122186 | K131082 | 000 |
| 00840314122506 | K131082 | 000 |
| 00840314122988 | K131082 | 000 |
| 00840314128027 | K131082 | 000 |
| 00840314100436 | K131082 | 000 |