DePuy Synthes Hammertoe Continuous Compression Implant— 510(k) K191463
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K191463 for DePuy Synthes Hammertoe Continuous Compression Implant, Substantially Equivalent on 2020-02-26. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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Adverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
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 K191463
K-number listed on FDA's recall record- Z-0101-2023 — DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
- Z-0008-2023 — Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191463.
Data sourced from openFDA. This site is unofficial and independent of the FDA.