The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Oregon Fixation System Interference Screw.
| Device ID | K932027 |
| 510k Number | K932027 |
| Device Name: | OREGON FIXATION SYSTEM INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Gene Conrad |
| Correspondent | Gene Conrad ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-26 |
| Decision Date | 1994-02-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010507532 | K932027 | 000 |
| 03596010249913 | K932027 | 000 |
| 03596010249920 | K932027 | 000 |
| 03596010249937 | K932027 | 000 |
| 03596010249944 | K932027 | 000 |
| 03596010249968 | K932027 | 000 |
| 03596010249975 | K932027 | 000 |
| 03596010249982 | K932027 | 000 |
| 03596010249999 | K932027 | 000 |
| 03596010250001 | K932027 | 000 |
| 03596010250018 | K932027 | 000 |
| 03596010250025 | K932027 | 000 |
| 03596010250032 | K932027 | 000 |
| 03596010250049 | K932027 | 000 |
| 03596010249906 | K932027 | 000 |