Integrated Orbital Implants, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Integrated Orbital Implants, Inc.” (first 1989, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 105 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | 3 | 3 |
| MQU | Ocular Peg | 2 | 2 |
Review panels
- Ophthalmic (5)
Most recent Integrated Orbital Implants, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003338 | BIO-EYE II ORBITAL IMPLANT | HPZ | 2001-02-07 | 105 |
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | MQU | 2000-04-10 | 82 |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | HPZ | 1998-12-28 | 158 |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | MQU | 1998-02-04 | 86 |
| K891137 | MOTILITY ORBITAL IMPLANT | HPZ | 1989-08-24 | 174 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2011-05-20.
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.
- Integrated Display Technology, Ltd. (5 510(k)s)
- Integrated Medical Systems, Inc. (5 510(k)s)
- Integrated Biomedical Technology, Inc. (3 510(k)s)
- Integrated Endoscopy, Inc. (3 510(k)s)
- Integrated Surgical Systems, Inc. (3 510(k)s)
- Integrated Vascular Systems, Inc. (3 510(k)s)
- Integrated Healing Technologies (2 510(k)s)
- Integrated Medical Systems Int'L., Inc. (2 510(k)s)
- Integrated Biosensing Technologies (1 510(k)s)
- Integrated Biotechnology Corp. (1 510(k)s)
- Integrated Computerized Laboratory Systems, Inc. (1 510(k)s)
- Integrated Dental Systems, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Integrated Orbital Implants, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Integrated Orbital Implants, Inc.” (first 1989, latest 2001), across 2 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 Integrated Orbital Implants, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Integrated Orbital Implants, Inc. is 105 days.
Which FDA product codes appear under Integrated Orbital Implants, Inc.?
The most frequent FDA product codes under this applicant name are HPZ (Implant, Eye Sphere, 3); MQU (Ocular Peg, 2).
Next steps
- See all 5 Integrated Orbital Implants, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPZ, Integrated Orbital Implants, Inc.'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.