The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for 2.7mm Lcp Ulna Osteotomy System.
| Device ID | K113364 |
| 510k Number | K113364 |
| Device Name: | 2.7MM LCP ULNA OSTEOTOMY SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1230 Wilson Dr West Chester, PA 19380 |
| Contact | Rebecca Blank |
| Correspondent | Rebecca Blank SYNTHES (USA) PRODUCTS LLC 1230 Wilson Dr West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-15 |
| Decision Date | 2012-02-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679031119040 | K113364 | 000 |
| H679021119000 | K113364 | 000 |
| H67904111901S0 | K113364 | 000 |
| H679041119010 | K113364 | 000 |
| H67904111900S0 | K113364 | 000 |
| H679041119000 | K113364 | 000 |
| 10886982341211 | K113364 | 000 |
| 10886982341204 | K113364 | 000 |
| 10886982341198 | K113364 | 000 |
| 10886982341181 | K113364 | 000 |
| H67902111900S0 | K113364 | 000 |
| H679021119010 | K113364 | 000 |
| H67902111901S0 | K113364 | 000 |
| H679031119030 | K113364 | 000 |
| H679031119020 | K113364 | 000 |
| H679031119010 | K113364 | 000 |
| H679031119000 | K113364 | 000 |
| H679031119070 | K113364 | 000 |
| H679031119060 | K113364 | 000 |
| H679031119050 | K113364 | 000 |
| H67902111903010 | K113364 | 000 |
| H67902111902010 | K113364 | 000 |
| 10886982341174 | K113364 | 000 |