PMT BONE SCREWS— 510(k) K121713
Substantially EquivalentProvidence Medical Technology, Inc.
FDA 510(k) clearance K121713 for PMT BONE SCREWS, Substantially Equivalent on 2012-09-27. Applicant: Providence Medical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Providence Medical Technology, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lafayette, CA, US
Recent devices under product code HWC
view allMore clearances from Providence Medical Technology, Inc.
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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 K121713
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 K121713.
Data sourced from openFDA. This site is unofficial and independent of the FDA.