EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
FDA 510(k) clearance K093978 · decided 2010-05-11
Clearance details
- K-number
- K093978
- Device name
- EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
- Applicant
- Exactech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-12-24
- Decision date
- 2010-05-11
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S021) | Exactech, Inc. | 2017-04-03 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S020) | Exactech, Inc. | 2016-09-28 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (P050039/S019) | Exactech, Inc. | 2016-07-21 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S017) | Exactech, Inc. | 2016-04-26 |
| NOVATION CERAMIC ARTICULATION HIP SYSTEM (AHS) (P050039/S018) | Exactech, Inc. | 2015-12-30 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016) | Exactech, Inc. | 2014-06-18 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S015) | Exactech, Inc. | 2013-02-07 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S014) | Exactech, Inc. | 2012-12-05 |