Quantum Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Quantum Orthopedics, Inc.” (first 2004, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | 4 | 4 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Quantum Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062004 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT | MQP | 2006-08-15 | 29 |
| K061576 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | 2006-07-03 | 26 |
| K052641 | MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT | MQP | 2006-04-12 | 198 |
| K060491 | QUANTUM ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2006-03-13 | 17 |
| K050449 | QUANTUM VERTEBRAL BODY REPLACEMENT | MQP | 2005-07-07 | 135 |
| K040276 | QUANTUM CEMENT RESTRICTOR | JDK | 2004-04-30 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Quantum Orthopedics, 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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Quantum Orthopedics, Inc. (5)
- Quantum Orthopedics (1)
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.
- Quantum Medical Imaging, LLC (5 510(k)s)
- Quantum Medical Systems, Inc. (5 510(k)s)
- Quantum Bioengineering, Ltd. (4 510(k)s)
- Quantum Devices, Inc. (2 510(k)s)
- Quantum Instruments Corp. (2 510(k)s)
- Quantum Co., Ltd. (2 510(k)s)
- Quantum Medical Concepts, LLC (2 510(k)s)
- Quantum Surgical Sas (2 510(k)s)
- Quantum, Inc. (1 510(k)s)
- Quantum Dental Technologies, Inc. (1 510(k)s)
- Quantum Diagnostics, Ltd. (1 510(k)s)
- Quantum Intl. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quantum Orthopedics, Inc.?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Quantum Orthopedics, Inc.” (first 2004, latest 2006), 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 Quantum Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantum Orthopedics, Inc. is 57 days.
Which FDA product codes appear under Quantum Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are MQP (Spinal Vertebral Body Replacement Device, 4); JDK (Prosthesis, Hip, Cement Restrictor, 1); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 6 Quantum Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQP, Quantum Orthopedics, 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.