Interpore Cross Intl.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Interpore Cross Intl.” (first 1998, latest 2005), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 52 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 | 10 | 10 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 7 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 | 6 |
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| CAC | Apparatus, Autotransfusion | 2 | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 2 | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (34)
- Cardiovascular (2)
- General Hospital (2)
- Gastroenterology and Urology (1)
Most recent Interpore Cross Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050861 | PEEK CAS | MQP | 2005-05-27 | 52 |
| K031399 | INTERGRO DBM | MQV | 2005-02-18 | 655 |
| K041407 | TITANIUM MESH IMPLANT | MQP | 2004-12-29 | 216 |
| K043229 | MODIFICATION TO ALTIUS OCT SYSTEM | KWP | 2004-12-21 | 29 |
| K042798 | C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2004-11-04 | 27 |
| K040928 | EXPANDABLE PEEK VBR IMPLANT | MQP | 2004-08-27 | 140 |
| K041794 | C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2004-07-19 | 17 |
| K041449 | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT | KWP | 2004-07-01 | 30 |
| K033961 | ALTIUS OCT SYSTEM | KWP | 2004-04-14 | 114 |
| K040168 | MODIFICATION TO GEO STRUCTURE | MQP | 2004-04-08 | 73 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Interpore Cross Intl..
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.
- Interpore Intl. (25 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Interpore Cross Intl.?
FDA lists 39 510(k) clearances under the applicant name “Interpore Cross Intl.” (first 1998, latest 2005), across 11 product codes in 4 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 Interpore Cross Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interpore Cross Intl. is 52 days.
Which FDA product codes appear under Interpore Cross Intl.?
The most frequent FDA product codes under this applicant name are MQP (Spinal Vertebral Body Replacement Device, 10); KWP (Appliance, Fixation, Spinal Interlaminal, 7); MNI (Orthosis, Spinal Pedicle Fixation, 6).
Next steps
- See all 39 Interpore Cross Intl. clearances with predicates and recalls
- Run predicate analysis for product code MQP, Interpore Cross Intl.'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.