BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM— 510(k) K970897
Substantially EquivalentBiodynamic Technologies, Inc.
FDA 510(k) clearance K970897 for BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM, Substantially Equivalent on 1997-04-21. Applicant: Biodynamic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Biodynamic Technologies, Inc.
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Beach, FL, US
Recent devices under product code HSB
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- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Biodynamic Technologies, Inc.
view allAdverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.