AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
FDA 510(k) clearance K172351 · decided 2017-10-30
Clearance details
- K-number
- K172351
- Device name
- AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-03
- Decision date
- 2017-10-30
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, o recall (Z-0281-2024) | Encore Medical, LP | 2023-11-08 |
| DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108 recall (Z-2607-2023) | Encore Medical, LP | 2023-09-19 |