Biodynamic Technologies, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Biodynamic Technologies, Inc.” (first 1985, latest 1999), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 6 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| HTR | Rasp | 3 | 3 |
| JDQ | Cerclage, Fixation | 3 | 3 |
| BXB | Exerciser, Powered | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
Plus 6 more product codes.
Review panels
Most recent Biodynamic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | HSB | 1999-03-31 | 48 |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | HWC | 1999-03-17 | 27 |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | HRS | 1999-03-17 | 29 |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | HSB | 1998-06-01 | 59 |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | HSB | 1998-04-03 | 81 |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | HWC | 1998-03-12 | 83 |
| K972403 | BTI CORTICAL BONE SCREWS | HWC | 1997-08-29 | 64 |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | HSB | 1997-04-21 | 41 |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | HWC | 1996-11-13 | 124 |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | HWC | 1996-11-04 | 95 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biodynamic Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biodynamic Technologies of Florida (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biodynamic Technologies, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Biodynamic Technologies, Inc.” (first 1985, latest 1999), across 16 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biodynamic Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biodynamic Technologies, Inc. is 80 days.
Which FDA product codes appear under Biodynamic Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 6); HWC (Screw, Fixation, Bone, 5); HTR (Rasp, 3).
Next steps
- See all 30 Biodynamic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Biodynamic Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.