The following data is part of a premarket notification filed by Acme Spine, Llc. with the FDA for Acme Talon Pedicle Screw.
| Device ID | K071824 |
| 510k Number | K071824 |
| Device Name: | ACME TALON PEDICLE SCREW |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ACME SPINE, LLC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J. D Webb |
| Correspondent | J. D Webb ACME SPINE, LLC. 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-09-04 |
| Summary: | summary |