The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Outologous Spinal Fixation System.
| Device ID | K040493 |
| 510k Number | K040493 |
| Device Name: | OUTOLOGOUS SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ORTHOPEDIC SCIENCES, INC 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson ORTHOPEDIC SCIENCES, INC 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2004-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813892021073 | K040493 | 000 |
| 00813892020908 | K040493 | 000 |
| 00813892020892 | K040493 | 000 |
| 00813892020885 | K040493 | 000 |
| 00813892020878 | K040493 | 000 |
| 00813892020861 | K040493 | 000 |
| 00813892020854 | K040493 | 000 |
| 00813892020847 | K040493 | 000 |
| 00813892020830 | K040493 | 000 |
| 00813892020823 | K040493 | 000 |
| 00813892020816 | K040493 | 000 |
| 00813892020809 | K040493 | 000 |
| 00813892020793 | K040493 | 000 |
| 00813892020786 | K040493 | 000 |
| 00813892020915 | K040493 | 000 |
| 00813892020922 | K040493 | 000 |
| 00813892020939 | K040493 | 000 |
| 00813892021066 | K040493 | 000 |
| 00813892021059 | K040493 | 000 |
| 00813892021042 | K040493 | 000 |
| 00813892021035 | K040493 | 000 |
| 00813892021028 | K040493 | 000 |
| 00813892021011 | K040493 | 000 |
| 00813892021004 | K040493 | 000 |
| 00813892020991 | K040493 | 000 |
| 00813892020984 | K040493 | 000 |
| 00813892020977 | K040493 | 000 |
| 00813892020960 | K040493 | 000 |
| 00813892020953 | K040493 | 000 |
| 00813892020946 | K040493 | 000 |
| 00813892020779 | K040493 | 000 |