ENCORE HUMERAL SHOULDER STEM
FDA 510(k) clearance K141990 · decided 2014-11-07
Clearance details
- K-number
- K141990
- Device name
- ENCORE HUMERAL SHOULDER STEM
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-22
- Decision date
- 2014-11-07
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- PHX
- 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 |
|---|---|---|
| AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qt recall (Z-1241-2018) | Encore Medical, Lp | 2018-03-05 |
| AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number recall (Z-0626-2016) | Encore Medical, Lp | 2016-01-09 |
| AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is inten recall (Z-0131-2016) | Encore Medical, Lp | 2015-10-16 |