APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
FDA 510(k) clearance K112779 · decided 2011-12-02
Clearance details
- K-number
- K112779
- Device name
- APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
- Applicant
- Omnlife Science
- Decision
- Substantially Equivalent
- Date received
- 2011-09-26
- Decision date
- 2011-12-02
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- East Taunton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-1135 recall (Z-2445-2015) | Omnilife Science Inc. | 2015-08-21 |