The following data is part of a premarket notification filed by Orthopedic Source Inc. with the FDA for Modification To Avalon Cup System.
| Device ID | K022711 |
| 510k Number | K022711 |
| Device Name: | MODIFICATION TO AVALON CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ORTHOPEDIC SOURCE INC. 5975 HORSESHOE BAR RD. P.O. BOX 307 Loomis, CA 95650 |
| Contact | Steven M Mandell |
| Correspondent | Steven M Mandell ORTHOPEDIC SOURCE INC. 5975 HORSESHOE BAR RD. P.O. BOX 307 Loomis, CA 95650 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-14 |
| Decision Date | 2002-08-26 |
| Summary: | summary |