The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Small Adjustable Clamp-mr Safe Line Extension.
| Device ID | K050631 |
| 510k Number | K050631 |
| Device Name: | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-11 |
| Decision Date | 2005-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792947730 | K050631 | 000 |
| H6793956820 | K050631 | 000 |
| H6793956850 | K050631 | 000 |
| H6793956860 | K050631 | 000 |
| H6793956870 | K050631 | 000 |
| H6793956880 | K050631 | 000 |
| H6792947670 | K050631 | 000 |
| H6792947680 | K050631 | 000 |
| H6792947710 | K050631 | 000 |
| H6792947720 | K050631 | 000 |
| H6793956810 | K050631 | 000 |