Hand Innovations, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Hand Innovations, Inc.” (first 2000, latest 2005), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 3 | 3 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Hand Innovations, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | LXT | 2005-04-26 | 12 |
| K042059 | SHOULDER FIXATION SYSTEM | LXT | 2004-09-30 | 62 |
| K041157 | MODIFICATION TO SMALL BONE FIXATION SYSTEM | HTY | 2004-07-30 | 88 |
| K041081 | FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES | KTT | 2004-07-01 | 66 |
| K033406 | SMALL BONE FIXATION SYSTEM | HTY | 2004-01-15 | 83 |
| K032705 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | LXT | 2003-10-01 | 29 |
| K030198 | HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM | HRS | 2003-04-01 | 70 |
| K023007 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | HRS | 2002-12-05 | 87 |
| K013424 | INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND | HTY | 2001-12-20 | 66 |
| K002775 | DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM | HRS | 2000-12-05 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Hand Innovations, 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.
- Hand Biomechanics Lab, Inc. (9 510(k)s)
- Hand Innovations, LLC (7 510(k)s)
- The Hand Biomechanics Research Laboratory (1 510(k)s)
- Hand Care, Inc., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hand Innovations, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Hand Innovations, Inc.” (first 2000, latest 2005), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hand Innovations, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hand Innovations, Inc. is 68 days.
Which FDA product codes appear under Hand Innovations, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HTY (Pin, Fixation, Smooth, 3); LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, 3).
Next steps
- See all 10 Hand Innovations, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Hand Innovations, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.