FDA 510(k) Applications for Medical Device:
Prosthesis, Toe, Constrained, Polymer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K994326 | BIOMET MANUFACTURING, INC. |
AIRPORT INDUSTRIAL PARK | WARSAW | IN | 46581-0587 |
| K191966 | BRM Extremities |
Via Ciro Menotti 10 | Milano | MI | 20129 |
| K190136 | Fusion Orthopedics, LLC |
4135 S. Power Rd., Suite 110 | Mesa | AZ | 85212 |
| K173491 | In2Bones USA, LLC |
6060 Poplar Ave, Suite 380 | Memphis | TN | 38119 |
| K153609 | In2BonesUSA, LLC |
6060 Poplar Ave, Suite 380 | Mephis | TN | 38119 |
| K023086 | NEXA ORTHOPEDICS, INC. |
990 PARK CENTER DR., SUITE H | VISTA | CA | 92083 |
| K981194 | NEXA ORTHOPEDICS, INC. |
9369 CARROLL PARK DR., SUITE A | SAN DIEGO | CA | 92121 |
| K023531 | NEXA ORTHOPEDICS, INC. |
990 PARK CENTER DR., SUITE H | VISTA | CA | 92083 |
| K023562 | NEXA ORTHOPEDICS, INC. |
990 PARK CENTER DR., SUITE H | VISTA | CA | 92083 |
| K102601 | ORTHO-PRO LLC |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K022887 | OSTEOMED CORP. |
3750 REALTY RD. | ADDISON | TX | 75001-4311 |
| K022886 | OSTEOMED CORP. |
3750 REALTY RD. | ADDISON | TX | 75001-4311 |
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