AMATOMICAL SHOULDER WITH REMOVABLE HEAD— 510(k) K030259
Substantially EquivalentCenterplus Orthopedics, Inc.
FDA 510(k) clearance K030259 for AMATOMICAL SHOULDER WITH REMOVABLE HEAD, Substantially Equivalent on 2003-04-24. Applicant: Centerplus Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Centerplus Orthopedics, Inc.
- Product code
- Code KWS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KWS
view allMore clearances from Centerplus Orthopedics, Inc.
view allAdverse events under product code KWS
product code KWS- Death
- 6
- Injury
- 9,652
- Malfunction
- 1,385
- Other
- 1
- Total
- 11,044
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 K030259
K-number listed on FDA's recall record- Z-0223-2013 — Anatomical Shoulder" Humeral stem
- Z-0227-2013 — Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
- Z-0232-2013 — Anatomical Shoulder" Ball taper for humeral stem
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030259.
Data sourced from openFDA. This site is unofficial and independent of the FDA.