FDA Product Code
FDA Product Code LZY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3360
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231448 | TANDEM Hip System | Smith & Nephew, Inc. | 2023-07-19 | Traditional | PDF ↗ |
| K111145 | ENDO HEAD | Medacta International | 2011-08-16 | Traditional | PDF ↗ |
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | P.T. Latexindo Tobaperkasa | 1998-01-05 | Traditional | PDF ↗ |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Implantology Corp. | 1993-06-29 | Traditional | PDF ↗ |
| K915548 | IONGUARD TITANIUM MODULAR HEADS | Biomet, Inc. | 1992-03-10 | Traditional | PDF ↗ |
| K903084 | MODULAR CATHCART FRACTURE SYSTEM | Depuy, Inc. | 1990-10-03 | Traditional | PDF ↗ |
| K896580 | UNI-POLAR HEAD | Richards Medical Co., Inc. | 1990-02-15 | Traditional | PDF ↗ |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Protek, Inc. | 1989-07-19 | Traditional | PDF ↗ |
Product code LZY · Class II · Orthopedic. Data: openFDA.