FDA 510(k) Applications for Medical Device:
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K100048 | BIOMET MANUFACTURING CORP. |
PO BOX 587 | WARSAW | IN | 46581-0587 |
| K101433 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K103756 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K201347 | DePuy Orthopaedics, Inc. |
700 Orthopaedic Drive | Warsaw | IN | 46582 |
| K111433 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K113756 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K103223 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K091956 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K121727 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K120038 | RENOVIS SURGICAL TECHNOLOGIES, LLC |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
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