The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Proximal Humerus Fracture Plate System.
| Device ID | K093978 |
| 510k Number | K093978 |
| Device Name: | EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Shing Jen Tai |
| Correspondent | Shing Jen Tai EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862088970 | K093978 | 000 |
| 10885862262387 | K093978 | 000 |
| 10885862262394 | K093978 | 000 |
| 10885862262400 | K093978 | 000 |
| 10885862262417 | K093978 | 000 |
| 10885862287861 | K093978 | 000 |
| 10885862287878 | K093978 | 000 |
| 10885862088949 | K093978 | 000 |
| 10885862088956 | K093978 | 000 |
| 10885862262370 | K093978 | 000 |
| 10885862262363 | K093978 | 000 |
| 10885862262356 | K093978 | 000 |
| 10885862089007 | K093978 | 000 |
| 10885862089014 | K093978 | 000 |
| 10885862089038 | K093978 | 000 |
| 10885862181022 | K093978 | 000 |
| 10885862210708 | K093978 | 000 |
| 10885862210722 | K093978 | 000 |
| 10885862230973 | K093978 | 000 |
| 10885862230980 | K093978 | 000 |
| 10885862088987 | K093978 | 000 |
| 10885862169853 | K093978 | 000 |
| 10885862181039 | K093978 | 000 |
| 10885862181053 | K093978 | 000 |
| 10885862181077 | K093978 | 000 |
| 10885862230911 | K093978 | 000 |
| 10885862230928 | K093978 | 000 |
| 10885862230935 | K093978 | 000 |
| 10885862230966 | K093978 | 000 |
| 10885862234278 | K093978 | 000 |
| 10885862262332 | K093978 | 000 |
| 10885862181046 | K093978 | 000 |
| 10885862180995 | K093978 | 000 |
| 10885862180988 | K093978 | 000 |
| 10885862088888 | K093978 | 000 |
| 10885862088895 | K093978 | 000 |
| 10885862088901 | K093978 | 000 |
| 10885862088918 | K093978 | 000 |
| 10885862088963 | K093978 | 000 |
| 10885862088994 | K093978 | 000 |
| 10885862180964 | K093978 | 000 |
| 10885862180971 | K093978 | 000 |
| 10885862262349 | K093978 | 000 |