Isotis NV: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Isotis NV” (first 2000, latest 2007), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| LZN | Cement Obturator | 2 | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 2 |
| NUN | Bone Grafting Material, Human Source | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Orthopedic (4)
- Dental (3)
- General Hospital (1)
Most recent Isotis NV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061880 | ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC | MQV | 2007-08-15 | 408 |
| K060332 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | NUN | 2006-03-29 | 48 |
| K060306 | ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY | NUN | 2006-03-27 | 48 |
| K031813 | OSSATURA DENTAL | LYC | 2004-08-20 | 435 |
| K041344 | OPEN BORE SYRINGE | FMF | 2004-07-16 | 57 |
| K030131 | OSSATURA BCP BONE VOID FILLER | MQV | 2003-05-20 | 126 |
| K010840 | SYNPLUG | LZN | 2001-04-20 | 30 |
| K000587 | SHUTTLE STOP | LZN | 2000-05-04 | 72 |
Recalls
openFDA lists no recalls under a recalling firm named Isotis NV.
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.
- Isotis Orthobiologics, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Isotis NV?
FDA lists 8 510(k) clearances under the applicant name “Isotis NV” (first 2000, latest 2007), across 5 product codes in 3 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 Isotis NV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Isotis NV is 64 days.
Which FDA product codes appear under Isotis NV?
The most frequent FDA product codes under this applicant name are LZN (Cement Obturator, 2); MQV (Filler, Bone Void, Calcium Compound, 2); NUN (Bone Grafting Material, Human Source, 2).
Next steps
- See all 8 Isotis NV clearances with predicates and recalls
- Run predicate analysis for product code LZN, Isotis NV'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.