Interpore Intl.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Interpore Intl.” (first 1984, latest 1998), plus 1 PMA decision, across 8 product codes in 4 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 12 | 12 |
| LYC | Bone Grafting Material, Synthetic | 6 | 6 |
| DZL | Screw, Fixation, Intraosseous | 2 | 2 |
| EGG | Attachment, Precision, All | 2 | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | 1 | 0 |
Review panels
Most recent Interpore Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981253 | ULTRACON ULTRAFILTRATOR | FJI | 1998-12-11 | 249 |
| K980817 | PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L | MQV | 1998-09-25 | 206 |
| K972842 | INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE | LYC | 1997-10-30 | 90 |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | GCY | 1997-06-03 | 75 |
| K960945 | IMZ MEMBRANE TACK SYSTEM | DZL | 1996-05-24 | 77 |
| K960371 | INTERPORE THREADED IMPLANT | DZE | 1996-03-08 | 42 |
| K955492 | INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT | DZE | 1996-01-30 | 60 |
| K952167 | IMZ BONE TACK SYSTEM | DZL | 1995-11-21 | 197 |
| K950165 | INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS | LYC | 1995-03-28 | 70 |
| K922872 | INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. | DZE | 1994-07-25 | 770 |
15 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P860005 | PMA | PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER | 1992-10-29 |
Recalls
openFDA lists no recalls under a recalling firm named Interpore 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 Cross Intl. (39 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Interpore Intl.?
FDA lists 25 510(k) clearances under the applicant name “Interpore Intl.” (first 1984, latest 1998), plus 1 PMA decision, across 8 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 Intl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interpore Intl. is 90 days.
Which FDA product codes appear under Interpore Intl.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 12); LYC (Bone Grafting Material, Synthetic, 6); DZL (Screw, Fixation, Intraosseous, 2).
Next steps
- See all 25 Interpore Intl. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Interpore 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.