GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
FDA 510(k) clearance K121877 · decided 2013-02-12
Clearance details
- K-number
- K121877
- Device name
- GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
- Applicant
- Exactech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-28
- Decision date
- 2013-02-12
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- KWP
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Gainesville, FL, US
- Third-party review
- No
- Expedited review
- No
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| SOLSTICE OCT System (K142253) | Life Spine, Inc. | 2015-04-23 |
| SOLSTICE OCT System (K150229) | Life Spine, Inc. | 2015-04-07 |
| SOLSTICE OCT System (K143249) | Life Spine, Inc. | 2015-04-07 |
| OASYS System (K142741) | Stryker Corporation | 2015-01-15 |
| Caspian OCT/MESA Mini/DENALI Mini Spinal System (K142558) | K2m | 2014-12-22 |
| NEXTGEN ALTIUS OCT SYSTEM (K140734) | Ebi, LLC | 2014-12-15 |
| EXPEDIUM Spine System/Synapse System (K142460) | Johnson and Johnson | 2014-10-01 |
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 |