The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Cortical Screws.
| Device ID | K112583 |
| 510k Number | K112583 |
| Device Name: | SYNTHES CORTICAL SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Rebecca Blank |
| Correspondent | Rebecca Blank SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2011-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794005260 | K112583 | 000 |
| H679401506960 | K112583 | 000 |
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| 10886982307439 | K112583 | 000 |
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| H6794016260 | K112583 | 000 |