The following data is part of a premarket notification filed by Acumed Llc with the FDA for Slic Screw Repair System.
| Device ID | K111608 |
| 510k Number | K111608 |
| Device Name: | SLIC SCREW REPAIR SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUMED LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Hollace Rhodes |
| Correspondent | Hollace Rhodes ACUMED LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-09 |
| Decision Date | 2011-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378092923 | K111608 | 000 |
| 10806378092916 | K111608 | 000 |
| 10806378045271 | K111608 | 000 |
| 10806378045264 | K111608 | 000 |