The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.4mm Lcp Volar Column Distal Radius Plates.
| Device ID | K091644 |
| 510k Number | K091644 |
| Device Name: | SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY. 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 | 2009-06-04 |
| Decision Date | 2009-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792424640 | K091644 | 000 |
| H679021107310 | K091644 | 000 |
| H67902110731S0 | K091644 | 000 |
| H679021107400 | K091644 | 000 |
| H67902110740S0 | K091644 | 000 |
| H679021107410 | K091644 | 000 |
| H67902110741S0 | K091644 | 000 |
| H679021107500 | K091644 | 000 |
| H67902110750S0 | K091644 | 000 |
| H679021107510 | K091644 | 000 |
| H67902110751S0 | K091644 | 000 |
| H679021108300 | K091644 | 000 |
| H67902110830S0 | K091644 | 000 |
| H679021108310 | K091644 | 000 |
| H67902110831S0 | K091644 | 000 |
| H679021108400 | K091644 | 000 |
| H67902110840S0 | K091644 | 000 |
| H679021108410 | K091644 | 000 |
| H67902110730S0 | K091644 | 000 |
| H679021107300 | K091644 | 000 |
| H679021104510 | K091644 | 000 |
| H6792424650 | K091644 | 000 |
| H6792424670 | K091644 | 000 |
| H6792424680 | K091644 | 000 |
| H6792425010 | K091644 | 000 |
| H6792425030 | K091644 | 000 |
| H6792425050 | K091644 | 000 |
| H679021103300 | K091644 | 000 |
| H679021103310 | K091644 | 000 |
| H679021103400 | K091644 | 000 |
| H679021103410 | K091644 | 000 |
| H679021103500 | K091644 | 000 |
| H679021103510 | K091644 | 000 |
| H679021104300 | K091644 | 000 |
| H679021104310 | K091644 | 000 |
| H679021104400 | K091644 | 000 |
| H679021104410 | K091644 | 000 |
| H679021104500 | K091644 | 000 |
| H67902110841S0 | K091644 | 000 |
| H679021108500 | K091644 | 000 |
| H67902110850S0 | K091644 | 000 |
| H679041108300 | K091644 | 000 |
| H679041108310 | K091644 | 000 |
| H679041108400 | K091644 | 000 |
| H679041108410 | K091644 | 000 |
| H679041108500 | K091644 | 000 |
| H679041108510 | K091644 | 000 |
| H67904110730S0 | K091644 | 000 |
| H67904110731S0 | K091644 | 000 |
| H67904110750S0 | K091644 | 000 |
| H67904110830S0 | K091644 | 000 |
| H67904110831S0 | K091644 | 000 |
| H67904110840S0 | K091644 | 000 |
| H67904110740S0 | K091644 | 000 |
| H67904110741S0 | K091644 | 000 |
| H67904110751S0 | K091644 | 000 |
| H67904110841S0 | K091644 | 000 |
| H67904110850S0 | K091644 | 000 |
| H679041107510 | K091644 | 000 |
| H679041107500 | K091644 | 000 |
| H679041107410 | K091644 | 000 |
| H679021108510 | K091644 | 000 |
| H67902110851S0 | K091644 | 000 |
| H679041103300 | K091644 | 000 |
| H679041103310 | K091644 | 000 |
| H679041103400 | K091644 | 000 |
| H679041103410 | K091644 | 000 |
| H679041103500 | K091644 | 000 |
| H679041103510 | K091644 | 000 |
| H679041104300 | K091644 | 000 |
| H679041104310 | K091644 | 000 |
| H679041104400 | K091644 | 000 |
| H679041104410 | K091644 | 000 |
| H679041104500 | K091644 | 000 |
| H679041104510 | K091644 | 000 |
| H679041107300 | K091644 | 000 |
| H679041107310 | K091644 | 000 |
| H679041107400 | K091644 | 000 |
| H67904110851S0 | K091644 | 000 |