The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Universal Acetabular Component.
| Device ID | K861433 |
| 510k Number | K861433 |
| Device Name: | UNIVERSAL ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Judith Dermody |
| Correspondent | Judith Dermody BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-16 |
| Decision Date | 1986-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304044494 | K861433 | 000 |