Science For Biomaterials: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Science For Biomaterials” (first 2006, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 | 1 | 31 |
| 2013 | 0 | — |
| 2014 | 1 | 125 |
| 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 | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 2 |
Review panels
- Orthopedic (6)
Most recent Science For Biomaterials 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140226 | OTIS-C-PLUS, NEOTIS PLATE, SCREW 06.5 | HRS | 2014-06-03 | 125 |
| K120818 | OTIS-C PLUS | HRS | 2012-04-19 | 31 |
| K090994 | LIGAFIX INTERFACE SCREW | HWC | 2009-05-06 | 29 |
| K071155 | MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER | MQV | 2007-07-03 | 69 |
| K070507 | MODIFICATION TO: LIGAFIX INTERFERENCE SCREW | HWC | 2007-03-29 | 36 |
| K061022 | BIO 1-KIT BIOSORB FILLED CARTRIDGE | MQV | 2006-05-24 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Science For Biomaterials.
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.
- Science Development Corp. (9 510(k)s)
- Science Incorporated (4 510(k)s)
- Science & Bio Materials (S.B.M.) Sas (2 510(k)s)
- Science Regulatory Services Intl. (2 510(k)s)
- Science Surgical Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Science For Biomaterials?
FDA lists 6 510(k) clearances under the applicant name “Science For Biomaterials” (first 2006, 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 Science For Biomaterials?
The median time from FDA receipt to decision across 510(k)s cleared under the name Science For Biomaterials is 38 days.
Which FDA product codes appear under Science For Biomaterials?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 2); MQV (Filler, Bone Void, Calcium Compound, 2).
Next steps
- See all 6 Science For Biomaterials clearances with predicates and recalls
- Run predicate analysis for product code HRS, Science For Biomaterials'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.