ASCENSION MODULAR TOTAL SHOULDER SYSTEM— 510(k) K100448
Substantially EquivalentAscension Orthopedics, Inc.
FDA 510(k) clearance K100448 for ASCENSION MODULAR TOTAL SHOULDER SYSTEM, Substantially Equivalent on 2010-08-30. Applicant: Ascension Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ascension 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 Ascension 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 K100448
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 K100448.
Data sourced from openFDA. This site is unofficial and independent of the FDA.