LZYClass II
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
21 CFR 888.3360 / Orthopedic
LZY is the FDA product code for Prosthesis, Hip, Hemi-, Femoral, Metal Ball, a class II device type, regulated under 21 CFR 888.3360. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- LZY
- Device name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Regulation
- 21 CFR 888.3360
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 3
Clearances, product code LZY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 1998 | 1 |
| 2011 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code LZY| Applicant | Clearances |
|---|---|
| Zimmer GmbH | 1 |
| Depuy, Inc. | 1 |
| Implantology Corp. | 1 |
| Medacta International SA | 1 |
| P.T. Latexindo Tobaperkasa | 1 |
| Protek, Inc. | 1 |
| Richards Medical Co., Inc. | 1 |
| Smith & Nephew, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.