LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball Class II
FDA product code LZY covers "Prosthesis, Hip, Hemi-, Femoral, Metal Ball", a Class II medical device regulated under 21 CFR 888.3360. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZY
- Device Class
- Class II
- Regulation Number
- 888.3360
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231448 | smith and nephew | TANDEM Hip System | July 19, 2023 |
| K111145 | medacta international | ENDO HEAD | August 16, 2011 |
| K974442 | p.t. latexindo tobaperkasa | PRE-POWDERED NITRILE EXAMINATION GLOVES | January 5, 1998 |
| K915528 | implantology | BHR BIPOLAR FEMORAL HEAD COMPONENT | June 29, 1993 |
| K915548 | biomet | IONGUARD TITANIUM MODULAR HEADS | March 10, 1992 |
| K903084 | depuy | MODULAR CATHCART FRACTURE SYSTEM | October 3, 1990 |
| K896580 | richards medical co | UNI-POLAR HEAD | February 15, 1990 |
| K892059 | protek | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | July 19, 1989 |