FDA 510(k) Applications for Medical Device:
Bone Grafting Material, Human Source
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K070147 | BIOMET 3I |
4555 RIVERSIDE DRIVE | PALM BEACH GARDENS | FL | 33410 |
| K113645 | BIOMET INTERPORE CROSS |
181 TECHNOLOGY DRIVE | IRVINE | CA | 92618 |
| K103699 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K130235 | HANS BIOMED CORP. |
5600 WISCONSIN AVENUE #509 | CHEVY CHASE | MD | 20815 |
| K060306 | ISOTIS NV |
2 GOODYEAR, SUITE B | IRVINE | CA | 92618 |
| K060332 | ISOTIS NV |
PROF. BRONKHORSTLAAN 10-D | BILTHOVEN | 3723 MB | |
| K043573 | ISOTIS ORTHOBIOLOGICS, INC |
2 GOODYEAR, SUITE B | IRVINE | CA | 92618 |
| K082463 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K080462 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K081950 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K091217 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET | EDISON | NJ | 08837 |
| K040501 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET | EDISON | NJ | 08837 |
| K051188 | OSTEOTECH, INC. |
51 JAMES WAY | EATONTOWN | NJ | 07724 |
| K042707 | OSTEOTECH, INC. |
51 JAMES WAY | EATONTOWN | NJ | 07724 |
| K080418 | REGENERATION TECHNOLOGIES, INC. |
11621 RESEARCH CIR. | ALACHUA | FL | 32616-2650 |
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