PIONEER POSTERIOR CERVICO THORACIC SYSTEM— 510(k) K112757
Substantially EquivalentPioneer Surgical Technology, Inc.
FDA 510(k) clearance K112757 for PIONEER POSTERIOR CERVICO THORACIC SYSTEM, Substantially Equivalent on 2012-03-12. Applicant: Pioneer Surgical Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Pioneer Surgical Technology, Inc.
- Product code
- Code KWP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marquette, MI, US
Recent devices under product code KWP
view allMore clearances from Pioneer Surgical Technology, Inc.
view allAdverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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 K112757
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 K112757.
Data sourced from openFDA. This site is unofficial and independent of the FDA.