Applied Osteo Systems, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Applied Osteo Systems, Inc.” (first 1990, latest 1995), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 | 9 | 9 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
| JEC | Component, Traction, Invasive | 1 | 1 |
| JEL | Curette, Biopsy, Bronchoscope (Rigid) | 1 | 1 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 1 |
Review panels
- Orthopedic (14)
- Ear, Nose and Throat (1)
Most recent Applied Osteo Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935383 | FEMROD AND FEMROD RECON INSERT | HSB | 1995-03-21 | 498 |
| K933995 | TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION | HSB | 1995-01-27 | 528 |
| K944501 | TRUE/FLEX INTRAMEDULLARY ROD END-CAP | HSB | 1994-11-28 | 75 |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | LXT | 1994-10-03 | 210 |
| K943160 | INTERFERENCE SCREW | HWC | 1994-09-30 | 91 |
| K934148 | TRUE/FLEX CLAVICLE RODS | HSB | 1994-02-22 | 181 |
| K932853 | PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS | JEL | 1994-02-22 | 257 |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | JEC | 1994-02-22 | 329 |
| K926465 | FEMORAL INTRAMEDULLARY RODS | JDS | 1993-08-25 | 244 |
| K924657 | TRUE/FLEX METATARSAL RODS | KTW | 1992-11-24 | 70 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Applied Osteo Systems, 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.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Spectral Imaging , Ltd. (8 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Osteo Systems, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Applied Osteo Systems, Inc.” (first 1990, latest 1995), across 7 product codes in 2 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 Applied Osteo Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Osteo Systems, Inc. is 130 days.
Which FDA product codes appear under Applied Osteo Systems, Inc.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 9); HWC (Screw, Fixation, Bone, 1); JDS (Nail, Fixation, Bone, 1).
Next steps
- See all 15 Applied Osteo Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Applied Osteo Systems, 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.