The following data is part of a premarket notification filed by Dvo Extremity Solutions, Llc with the FDA for Dvo Extended Articulation Humeral Heads.
| Device ID | K073331 |
| 510k Number | K073331 |
| Device Name: | DVO EXTENDED ARTICULATION HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | DVO EXTREMITY SOLUTIONS, LLC 720 E WINONA AVE Warsaw, IN 46580 |
| Contact | Jeff Ondrla |
| Correspondent | Jeff Ondrla DVO EXTREMITY SOLUTIONS, LLC 720 E WINONA AVE Warsaw, IN 46580 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-27 |
| Decision Date | 2008-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832002245 | K073331 | 000 |
| 00846832002238 | K073331 | 000 |
| 00846832002221 | K073331 | 000 |
| 00846832002214 | K073331 | 000 |
| 00846832002207 | K073331 | 000 |
| 00846832002191 | K073331 | 000 |
| 00846832002184 | K073331 | 000 |