Orthopedic Sciences, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Orthopedic Sciences, Inc.” (first 2002, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 31 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 | 1 | 154 |
| 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 | 8 | 8 |
| HRX | Arthroscope | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Orthopedic Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133018 | OSI Q SYSTEM ARTHROSCOPES | HRX | 2014-02-26 | 154 |
| K091398 | ARTHROSCOPE | HRX | 2009-08-26 | 106 |
| K072175 | TITANIUM HIP TOOL LOCKING PLATE | HRS | 2007-08-21 | 15 |
| K063709 | TS-BONE HIP TOOL | HRS | 2007-01-04 | 21 |
| K063033 | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT | HRS | 2006-11-01 | 29 |
| K052538 | S-BONE HIP TOOL | HRS | 2005-10-07 | 22 |
| K051181 | CUSTOM-HIP TOOL | HRS | 2005-05-23 | 14 |
| K051032 | TITANIUM-HIP TOOL | HRS | 2005-05-23 | 31 |
| K040493 | OUTOLOGOUS SPINAL FIXATION SYSTEM | MNI | 2004-09-03 | 190 |
| K040850 | TSY SHOULDER PLATE IMPLANT | HRS | 2004-06-24 | 85 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Orthopedic Sciences, 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.
- Orthopedic Systems, Inc. (95 510(k)s)
- Orthopedic Equipment Co., Inc. (45 510(k)s)
- Orthopedic Designs, Inc. (4 510(k)s)
- Orthopedic Designs North America, Inc. (4 510(k)s)
- Orthopedic Alliance, LLC (3 510(k)s)
- Orthopedic Source, Inc. (3 510(k)s)
- Orthopedic Development, Inc. (2 510(k)s)
- Orthopedic Technology, Inc. (2 510(k)s)
- Orthopedic Technology Research, Inc. (2 510(k)s)
- Orthopedic Designs, Inc. (Odi) (1 510(k)s)
- Orthopedic Designs North America, Inc. (Odi-Na) (1 510(k)s)
- Orthopedic Driven Imaging, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthopedic Sciences, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Orthopedic Sciences, Inc.” (first 2002, latest 2014), across 3 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 Orthopedic Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthopedic Sciences, Inc. is 31 days.
Which FDA product codes appear under Orthopedic Sciences, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 8); HRX (Arthroscope, 2); MNI (Orthosis, Spinal Pedicle Fixation, 1).
Next steps
- See all 11 Orthopedic Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Orthopedic Sciences, 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.