The following data is part of a premarket notification filed by Acute Innovations Llc with the FDA for Acute Innovations Modular Ribloc System.
| Device ID | K113318 |
| 510k Number | K113318 |
| Device Name: | ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ACUTE INNOVATIONS LLC 21421 NW JACOBSON RD. SUITE 700 Hillsboro, OR 97124 |
| Contact | Mariah Knight |
| Correspondent | Mariah Knight ACUTE INNOVATIONS LLC 21421 NW JACOBSON RD. SUITE 700 Hillsboro, OR 97124 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2012-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378079160 | K113318 | 000 |
| 10806378079153 | K113318 | 000 |
| 10806378079146 | K113318 | 000 |
| 10806378079139 | K113318 | 000 |
| 10806378079122 | K113318 | 000 |
| 10806378079115 | K113318 | 000 |
| 10806378079108 | K113318 | 000 |
| 10806378079092 | K113318 | 000 |