SMR REVERSE SHOULDER SYSTEM— 510(k) K110598
Substantially EquivalentLima Corporate S.P.A.
FDA 510(k) clearance K110598 for SMR REVERSE SHOULDER SYSTEM, Substantially Equivalent on 2011-08-18. Applicant: Lima Corporate S.P.A.. Device class: 2.
Clearance details
- Applicant
- Lima Corporate S.P.A.
- Product code
- Code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winona Lake, IN, US
Recent devices under product code PHX
view allMore clearances from Lima Corporate S.P.A.
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110598
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110598.
Data sourced from openFDA. This site is unofficial and independent of the FDA.