Speed, Speed Shift, Speed Titan, Speed Arc— 510(k) K142292
Substantially EquivalentBiomedical Enterprises, Inc.
FDA 510(k) clearance K142292 for Speed, Speed Shift, Speed Titan, Speed Arc, Substantially Equivalent on 2014-11-17. Applicant: Biomedical Enterprises, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomedical Enterprises, Inc.
- 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
- San Antonio, TX, US
Recent devices under product code JDR
view allMore clearances from Biomedical Enterprises, Inc.
view allAdverse 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 K142292
K-number listed on FDA's recall record- Z-0098-2023 — SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery.
- Z-0099-2023 — SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Z-0100-2023 — SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142292.
Data sourced from openFDA. This site is unofficial and independent of the FDA.