The following data is part of a premarket notification filed by Synthes Usa, Llc with the FDA for Synthes Radial Head Prosthesis System.
| Device ID | K112030 |
| 510k Number | K112030 |
| Device Name: | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | SYNTHES USA, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Angela F Lassandro |
| Correspondent | Angela F Lassandro SYNTHES USA, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-15 |
| Decision Date | 2012-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679034027260 | K112030 | 000 |
| H679034024180 | K112030 | 000 |
| H679034022280 | K112030 | 000 |
| H679034022260 | K112030 | 000 |
| H679034022240 | K112030 | 000 |
| H679034022220 | K112030 | 000 |
| H679034022200 | K112030 | 000 |
| H679034022180 | K112030 | 000 |
| H679034021100 | K112030 | 000 |
| H679034021090 | K112030 | 000 |
| H679034024200 | K112030 | 000 |
| H679034024220 | K112030 | 000 |
| H679034026280 | K112030 | 000 |
| H679034026260 | K112030 | 000 |
| H679034026240 | K112030 | 000 |
| H679034026220 | K112030 | 000 |
| H679034026200 | K112030 | 000 |
| H679034026180 | K112030 | 000 |
| H679034024280 | K112030 | 000 |
| H679034024260 | K112030 | 000 |
| H679034024240 | K112030 | 000 |
| H679034021080 | K112030 | 000 |
| H679034021070 | K112030 | 000 |
| H679034021060 | K112030 | 000 |
| H679034027250 | K112030 | 000 |
| H679034027240 | K112030 | 000 |
| H679034027230 | K112030 | 000 |
| H679034027220 | K112030 | 000 |
| H679034027210 | K112030 | 000 |
| H679034027200 | K112030 | 000 |
| H679034027190 | K112030 | 000 |
| H679034027180 | K112030 | 000 |
| H679034027170 | K112030 | 000 |
| H679034020060 | K112030 | 000 |
| H679034020070 | K112030 | 000 |
| H679034020280 | K112030 | 000 |
| H679034020260 | K112030 | 000 |
| H679034020240 | K112030 | 000 |
| H679034020220 | K112030 | 000 |
| H679034020200 | K112030 | 000 |
| H679034020180 | K112030 | 000 |
| H679034020100 | K112030 | 000 |
| H679034020090 | K112030 | 000 |
| H679034020080 | K112030 | 000 |
| H679034027160 | K112030 | 000 |
| H679034027410 | K112030 | 000 |
| H67909402420S0 | K112030 | 000 |
| H67909402418S0 | K112030 | 000 |
| H67909402228S0 | K112030 | 000 |
| H67909402226S0 | K112030 | 000 |
| H67909402224S0 | K112030 | 000 |
| H67909402222S0 | K112030 | 000 |
| H67909402220S0 | K112030 | 000 |
| H67909402218S0 | K112030 | 000 |
| H67909402028S0 | K112030 | 000 |
| H67909402422S0 | K112030 | 000 |
| H67909402424S0 | K112030 | 000 |
| H679034027400 | K112030 | 000 |
| H67909402628S0 | K112030 | 000 |
| H67909402626S0 | K112030 | 000 |
| H67909402624S0 | K112030 | 000 |
| H67909402622S0 | K112030 | 000 |
| H67909402620S0 | K112030 | 000 |
| H67909402618S0 | K112030 | 000 |
| H67909402428S0 | K112030 | 000 |
| H67909402426S0 | K112030 | 000 |
| H67909402026S0 | K112030 | 000 |
| H67909402024S0 | K112030 | 000 |
| H67909402022S0 | K112030 | 000 |
| H67904402006S0 | K112030 | 000 |
| H679034027350 | K112030 | 000 |
| H679034027340 | K112030 | 000 |
| H679034027330 | K112030 | 000 |
| H679034027320 | K112030 | 000 |
| H679034027310 | K112030 | 000 |
| H679034027300 | K112030 | 000 |
| H679034027290 | K112030 | 000 |
| H679034027280 | K112030 | 000 |
| H67904402007S0 | K112030 | 000 |
| H67904402008S0 | K112030 | 000 |
| H67909402020S0 | K112030 | 000 |
| H67909402018S0 | K112030 | 000 |
| H67904402030S0 | K112030 | 000 |
| H67904402029S0 | K112030 | 000 |
| H67904402028S0 | K112030 | 000 |
| H67904402027S0 | K112030 | 000 |
| H67904402026S0 | K112030 | 000 |
| H67904402010S0 | K112030 | 000 |
| H67904402009S0 | K112030 | 000 |
| H679034027270 | K112030 | 000 |