FDA 510(k) Applications for Medical Device:
Orthopedic Manual Surgical Instrument
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101609 | KOROS USA, INC. |
610 FLINN AVE. | MOORPARK | CA | 93021 |
| K952495 | ORTHOPEDIC SYSTEMS, INC. |
30031 AHERN AVE. | UNION CITY | CA | 94587-1234 |
| K140414 | ORTHOVITA, INC. |
77 Great Valley Parkway | Malvern | PA | 19355 |
| K001507 | SMITH & NEPHEW, INC. |
130 FORBES BLVD. | MANSFIELD | MA | 02048 |
| K192873 | Sonex Health, Inc. |
11 1st Ave SW | Rochester | MN | 55902 |
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