The following data is part of a premarket notification filed by Dvo Extremity Solutions, Llc with the FDA for Total And Hemi Shoulder System.
| Device ID | K060988 |
| 510k Number | K060988 |
| Device Name: | TOTAL AND HEMI SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DVO EXTREMITY SOLUTIONS, LLC P.O. BOX 205 Derby, CT 06418 |
| Contact | Dina Weissman |
| Correspondent | Dina Weissman DVO EXTREMITY SOLUTIONS, LLC P.O. BOX 205 Derby, CT 06418 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832002252 | K060988 | 000 |
| 00846832001927 | K060988 | 000 |
| 00846832001910 | K060988 | 000 |
| 00846832001903 | K060988 | 000 |
| 00846832001897 | K060988 | 000 |
| 00846832001880 | K060988 | 000 |
| 00846832001873 | K060988 | 000 |
| 00846832001866 | K060988 | 000 |
| 00846832001859 | K060988 | 000 |
| 00846832001842 | K060988 | 000 |
| 00846832001835 | K060988 | 000 |
| 00846832001828 | K060988 | 000 |
| 00846832001811 | K060988 | 000 |
| 00846832001804 | K060988 | 000 |
| 00846832001798 | K060988 | 000 |
| 00846832001781 | K060988 | 000 |
| 00846832001774 | K060988 | 000 |
| 00846832001934 | K060988 | 000 |
| 00846832001941 | K060988 | 000 |
| 00846832001958 | K060988 | 000 |
| 00846832002115 | K060988 | 000 |
| 00846832002108 | K060988 | 000 |
| 00846832002092 | K060988 | 000 |
| 00846832002085 | K060988 | 000 |
| 00846832002078 | K060988 | 000 |
| 00846832002061 | K060988 | 000 |
| 00846832002054 | K060988 | 000 |
| 00846832002047 | K060988 | 000 |
| 00846832002030 | K060988 | 000 |
| 00846832002023 | K060988 | 000 |
| 00846832002016 | K060988 | 000 |
| 00846832002009 | K060988 | 000 |
| 00846832001996 | K060988 | 000 |
| 00846832001989 | K060988 | 000 |
| 00846832001972 | K060988 | 000 |
| 00846832001965 | K060988 | 000 |
| 00846832001767 | K060988 | 000 |