The following data is part of a premarket notification filed by Maxim Surgical with the FDA for Maxim Surgical X-treme Interbody Fusion System.
| Device ID | K123206 |
| 510k Number | K123206 |
| Device Name: | MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MAXIM SURGICAL 1565 NORTH CENTRAL EXPRESSWAY SUITE 200 Richardson, TX 75080 |
| Contact | Chris Reeg |
| Correspondent | Chris Reeg MAXIM SURGICAL 1565 NORTH CENTRAL EXPRESSWAY SUITE 200 Richardson, TX 75080 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-12 |
| Decision Date | 2013-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5651506L1 | K123206 | 000 |
| B5651708L1 | K123206 | 000 |
| B5651708N1 | K123206 | 000 |
| B5651709L1 | K123206 | 000 |
| B5651709N1 | K123206 | 000 |
| B5651710L1 | K123206 | 000 |
| B5651710N1 | K123206 | 000 |
| B5651790400011 | K123206 | 000 |
| B5651790400021 | K123206 | 000 |
| B565CI10011 | K123206 | 000 |
| B565CR1517051 | K123206 | 000 |
| B565CR1517061 | K123206 | 000 |
| B5651707N1 | K123206 | 000 |
| B5651707L1 | K123206 | 000 |
| B5651506N1 | K123206 | 000 |
| B5651507L1 | K123206 | 000 |
| B5651507N1 | K123206 | 000 |
| B5651508L1 | K123206 | 000 |
| B5651508N1 | K123206 | 000 |
| B5651509L1 | K123206 | 000 |
| B5651509N1 | K123206 | 000 |
| B5651510L1 | K123206 | 000 |
| B5651510N1 | K123206 | 000 |
| B5651706L1 | K123206 | 000 |
| B5651706N1 | K123206 | 000 |
| B565CR1517071 | K123206 | 000 |
| B565CR1517081 | K123206 | 000 |
| B565CR1517091 | K123206 | 000 |
| B565CT170601 | K123206 | 000 |
| B565CT17061 | K123206 | 000 |
| B565CT170701 | K123206 | 000 |
| B565CT17071 | K123206 | 000 |
| B565CT170801 | K123206 | 000 |
| B565CT17081 | K123206 | 000 |
| B565CT170901 | K123206 | 000 |
| B565CT17091 | K123206 | 000 |
| B565CT171001 | K123206 | 000 |
| B565CT17101 | K123206 | 000 |
| B565FP20011 | K123206 | 000 |
| B565CT170501 | K123206 | 000 |
| B565CT15101 | K123206 | 000 |
| B565CR1517101 | K123206 | 000 |
| B565CT150501 | K123206 | 000 |
| B565CT150601 | K123206 | 000 |
| B565CT15061 | K123206 | 000 |
| B565CT150701 | K123206 | 000 |
| B565CT15071 | K123206 | 000 |
| B565CT150801 | K123206 | 000 |
| B565CT15081 | K123206 | 000 |
| B565CT150901 | K123206 | 000 |
| B565CT15091 | K123206 | 000 |
| B565CT151001 | K123206 | 000 |
| B565MF2004C011 | K123206 | 000 |