The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Staple, Fixation Bone; Screw Fixation Bone.
| Device ID | K931155 |
| 510k Number | K931155 |
| Device Name: | STAPLE, FIXATION BONE; SCREW FIXATION BONE |
| Classification | Screw, Fixation, Bone |
| Applicant | ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
| Contact | Isabelle Floccia |
| Correspondent | Isabelle Floccia ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1994-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868010651 | K931155 | 000 |
| 00887868010644 | K931155 | 000 |
| 00887868010637 | K931155 | 000 |
| 00887868010620 | K931155 | 000 |
| 00887868115714 | K931155 | 000 |
| 00887868115707 | K931155 | 000 |
| 00887868115691 | K931155 | 000 |
| 00887868115684 | K931155 | 000 |