The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Ellison Vitallium Fixation Staple Sys.
| Device ID | K822943 |
| 510k Number | K822943 |
| Device Name: | ELLISON VITALLIUM FIXATION STAPLE SYS |
| Classification | Staple, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-04 |
| Decision Date | 1982-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613153182979 | K822943 | 000 |
| 07613153182962 | K822943 | 000 |
| 07613153182955 | K822943 | 000 |
| 07613153182948 | K822943 | 000 |
| 07613153182931 | K822943 | 000 |
| 07613153182924 | K822943 | 000 |
| 07613153077268 | K822943 | 000 |