Panels › Orthopedic › Product code LZY · Class 2
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Regulation 888.3360
0510(k)s in 12 months (8 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in LZY
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 1 | 1 |
| Biomet, Inc. | 1 | 0 |
| BioPro, Inc. | 0 | 1 |
| Depuy, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 0 | 1 |
| Implantology Corp. | 1 | 0 |
| Medacta International | 1 | 0 |
| P.T. Latexindo Tobaperkasa | 1 | 0 |
| Protek, Inc. | 1 | 0 |
| Richards Medical Co., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2023 | K231448 | TANDEM Hip System Smith & Nephew, Inc. | LZY |
| Aug 16, 2011 | K111145 | ENDO HEAD Medacta International | LZY |
| Jan 5, 1998 | K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES P.T. Latexindo Tobaperkasa, ID | LZY |
| Jun 29, 1993 | K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT Implantology Corp. | LZY |
| Mar 10, 1992 | K915548 | IONGUARD TITANIUM MODULAR HEADS Biomet, Inc. | LZY |
| Oct 3, 1990 | K903084 | MODULAR CATHCART FRACTURE SYSTEM Depuy, Inc. | LZY |
| Feb 15, 1990 | K896580 | UNI-POLAR HEAD Richards Medical Co., Inc. | LZY |
| Jul 19, 1989 | K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR Protek, Inc. | LZY |
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