The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Betacone Hip Prosthesis System.
| Device ID | K051826 |
| 510k Number | K051826 |
| Device Name: | BETACONE HIP PROSTHESIS SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | WALDEMAR LINK GMBH & CO. KG 1835 MARKET STREET 28TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan WALDEMAR LINK GMBH & CO. KG 1835 MARKET STREET 28TH FLOOR Philadelphia, PA 19103 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2005-11-18 |
| Summary: | summary |