ABG II MONOLITHIC HIP STEM
FDA 510(k) clearance K110807 · decided 2011-05-25
Clearance details
- K-number
- K110807
- Device name
- ABG II MONOLITHIC HIP STEM
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-23
- Decision date
- 2011-05-25
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- MAY
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, 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 |
| 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL (K090103) | Biomet, Inc. | 2009-02-11 |
| 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 |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |