EQUATOR PLUS ACETABULAR CUP SYSTEM
FDA 510(k) clearance K051844 · decided 2005-10-07
Clearance details
- K-number
- K051844
- Device name
- EQUATOR PLUS ACETABULAR CUP SYSTEM
- Applicant
- Portland Orthopaedics Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-07
- Decision date
- 2005-10-07
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- MAY
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Stillwater, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABG III MONOLITHIC HIP STEM (K123604) | Howmedica Osteonics Corp. | 2013-08-16 |
| ABG II MONOLITHIC HIP STEM (K110807) | Stryker Corp. | 2011-05-25 |
| 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (K090103) | Biomet, Inc. | 2009-02-11 |
Recalls involving this device
No recalls on record reference this clearance.