The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Porocoat Mark Ii Total Elbow.
| Device ID | K872084 |
| 510k Number | K872084 |
| Device Name: | POROCOAT MARK II TOTAL ELBOW |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Barry R Sisson |
| Correspondent | Barry R Sisson DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-29 |
| Decision Date | 1987-06-25 |