WAGNER REVISIONAL FEMORAL HIP PROSTHESIS— 510(k) K871347
Substantially EquivalentProtek, Inc.
FDA 510(k) clearance K871347 for WAGNER REVISIONAL FEMORAL HIP PROSTHESIS, Substantially Equivalent on 1987-07-01. Applicant: Protek, Inc.. Device class: 2.
Clearance details
- Applicant
- Protek, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Protek, Inc.
view allAdverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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 K871347
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 K871347.
Data sourced from openFDA. This site is unofficial and independent of the FDA.