Synergy Biomedical: FDA filings under this applicant name
FDA lists 3 510(k) clearances under 2 spellings of the applicant name “Synergy Biomedical” (first 2014, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 238 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 |
|---|---|---|
| 2014 | 1 | 105 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 315 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 238 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synergy Biomedical took a median 276 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 3 | 3 |
Review panels
- Orthopedic (3)
Most recent Synergy Biomedical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241167 | BioSphere Putty; BioSphere MIS Putty | MQV | 2024-12-20 | 238 |
| K173424 | BioSphere Flex | MQV | 2018-09-12 | 315 |
| K140844 | BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC | MQV | 2014-07-16 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Synergy Biomedical.
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:
- Synergy Biomedical (2)
- Synergy Biomedical, Inc. (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.
- Synergy Biomedical, LLC (2 510(k)s)
- Synergy Orthopaedics Intl., Inc. (2 510(k)s)
- Synergy Spine Solutions, Inc. (1 510(k)s)
- Synergy Surgical Technologies, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synergy Biomedical?
FDA lists 3 510(k) clearances under 2 spellings of the applicant name “Synergy Biomedical” (first 2014, latest 2024), across 1 product code 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 Synergy Biomedical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synergy Biomedical is 238 days.
Which FDA product codes appear under Synergy Biomedical?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 3).
Next steps
- See all 3 Synergy Biomedical clearances with predicates and recalls
- Run predicate analysis for product code MQV, Synergy Biomedical'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.