100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
FDA 510(k) clearance K090103 · decided 2009-02-11
Clearance details
- K-number
- K090103
- Device name
- 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-01-15
- Decision date
- 2009-02-11
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MAY
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| ABG III MONOLITHIC HIP STEM (K123604) | Howmedica Osteonics Corp. | 2013-08-16 |
| ABG II MONOLITHIC HIP STEM (K110807) | Stryker Corp. | 2011-05-25 |
| EQUATOR PLUS ACETABULAR CUP SYSTEM (K051844) | Portland Orthopaedics Pty. , Ltd. | 2005-10-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |