The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Modification To Passmed Spinal System.
| Device ID | K070276 |
| 510k Number | K070276 |
| Device Name: | MODIFICATION TO PASSMED SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J. D Webb |
| Correspondent | J. D Webb MEDICREA TECHNOLOGIES 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 | 2007-01-29 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720234999 | K070276 | 000 |
| 03613720234982 | K070276 | 000 |
| 03613720234975 | K070276 | 000 |
| 03613720234968 | K070276 | 000 |
| 03613720225980 | K070276 | 000 |
| 03613720225973 | K070276 | 000 |
| 03613720225966 | K070276 | 000 |
| 03613720225959 | K070276 | 000 |