The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Double Ball Joint.
| Device ID | K803166 |
| 510k Number | K803166 |
| Device Name: | DOUBLE BALL JOINT |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-15 |
| Decision Date | 1981-01-09 |