Biodynamic Technologies, Inc.
Arlington, VA, US
Biodynamic Technologies, Inc. appears in FDA device records in Arlington, VA. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Biodynamic Technologies, Inc. between 1985 and 1999. The busiest year on record is 1996, with 6. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 5 |
| 1996 | 6 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | HWC | Substantially Equivalent | |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | HWC | Substantially Equivalent for Some Indications | |
| K972403 | BTI CORTICAL BONE SCREWS | HWC | Substantially Equivalent | |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | LXT | Substantially Equivalent | |
| K962552 | EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K962553 | EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | |
| K954838 | EZ FIX | JEC | Substantially Equivalent | |
| K935593 | ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM | HSD | Substantially Equivalent | |
| K932918 | TOTAL KNEE KIT | HWE | Substantially Equivalent | |
| K926216 | BONE CEMENT RESTRICTOR | JDK | Substantially Equivalent | |
| K935646 | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM | JDQ | Substantially Equivalent for Some Indications | |
| K931540 | UNIVERSAL BONE CEMENT KIT | LZN | Substantially Equivalent | |
| K924323 | THE UNIVERSAL BONE CEMENT RESISTOR | JDI | Substantially Equivalent | |
| K915259 | FX-CABLELOK SYSTEM, MODIFICATION | JDQ | Substantially Equivalent | |
| K912207 | FX-CABLELOK SYSTEM | JDQ | Substantially Equivalent | |
| K870402 | MOBILIMB HAND EXERCISER | BXB | Substantially Equivalent | |
| K870349 | BIODYNAMICS FEMORAL CANAL BRUSH #1201 | HTR | Substantially Equivalent | |
| K870333 | BIODYNAMICS SMALL JOINT BRUSH #1203 | HTR | Substantially Equivalent | |
| K870329 | ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 | HTR | Substantially Equivalent | |
| K861164 | OSTEOMILL BONE GRINDER | LYS | Substantially Equivalent | |
| K851205 | CEMENTRIFUGE | JDZ | Substantially Equivalent | |
| K851177 | UNIVERSAL POWER FLEX | BXB | Substantially Equivalent | |
| K851206 | SHOULDER-HOLDER | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- LYSBone Mill
- LZNCement Obturator
- JDQCerclage, Fixation
- JECComponent, Traction, Invasive
- BXBExerciser, Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- JDZMixer, Cement, For Clinical Use
- HRSPlate, Fixation, Bone
- JDKProsthesis, Hip, Cement Restrictor
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HTRRasp
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain