BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
FDA 510(k) clearance K111908 · decided 2011-11-29
Clearance details
- K-number
- K111908
- Device name
- BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
- Applicant
- Biomet Microfixation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-05
- Decision date
- 2011-11-29
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Total Temporomandibular Joint Replacement System (P020016/S011) | Biomet Microfixation, Inc. | 2019-12-17 |
| TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM (P020016/S008) | Biomet Microfixation, Inc. | 2017-06-08 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S007) | Biomet Microfixation, Inc. | 2014-12-09 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S006) | Biomet Microfixation, Inc. | 2012-03-15 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S005) | Biomet Microfixation, Inc. | 2010-11-08 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S004) | Biomet Microfixation, Inc. | 2010-01-29 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S003) | Biomet Microfixation, Inc. | 2009-10-21 |
| TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S002) | Biomet Microfixation, Inc. | 2006-10-13 |