The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Extremity Bone Screw.
| Device ID | K963118 |
| 510k Number | K963118 |
| Device Name: | EXTREMITY BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari L Jeffers |
| Correspondent | Shari L Jeffers 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 | 1996-08-12 |
| Decision Date | 1996-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378066283 | K963118 | 000 |
| 10806378014871 | K963118 | 000 |
| 10806378014888 | K963118 | 000 |
| 10806378014895 | K963118 | 000 |
| 10806378014901 | K963118 | 000 |
| 10806378014918 | K963118 | 000 |
| 10806378014925 | K963118 | 000 |
| 10806378014932 | K963118 | 000 |
| 10806378014949 | K963118 | 000 |
| 10806378014956 | K963118 | 000 |
| 10806378014963 | K963118 | 000 |
| 10806378014970 | K963118 | 000 |
| 10806378014987 | K963118 | 000 |
| 10806378014994 | K963118 | 000 |
| 10806378014864 | K963118 | 000 |