Implantech Associates, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Implantech Associates, Inc.” (first 1989, latest 2020), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 71 days. Since 2017 the median was 289 days, against 110 days for all cleared 510(k)s in the same product codes. 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 | 1 | 79 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 344 |
| 2019 | 1 | 116 |
| 2020 | 1 | 289 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Implantech Associates, Inc. took a median 289 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 16 | 16 |
| LZK | Implant, Malar | 11 | 11 |
| FZE | Prosthesis, Nose, Internal | 7 | 7 |
| MDA | Elastomer, Silicone, For Scar Management | 3 | 3 |
| MIB | Elastomer, Silicone Block | 2 | 2 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| FZD | Prosthesis, Ear, Internal | 1 | 1 |
Review panels
Most recent Implantech Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200610 | Customized Contour Implant | FWP | 2020-12-23 | 289 |
| K191130 | Customized Contour Implant | FWP | 2019-08-23 | 116 |
| K172389 | ePTFE-Coated Auricular Implant | FZD | 2018-07-18 | 344 |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | FWP | 2014-07-10 | 79 |
| K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | FTL | 2007-08-31 | 94 |
| K052505 | CALF IMPLANT, MODEL EC17-X | MIB | 2005-11-04 | 52 |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | MIB | 2005-11-04 | 52 |
| K013732 | GELZONE | MDA | 2002-02-07 | 90 |
| K012419 | CONFORM SHEETING, MODEL IGEL | MDA | 2001-10-24 | 86 |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | LZK | 2000-11-24 | 70 |
31 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-01-29.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Implantech Associates, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Implantech Associates, Inc.” (first 1989, latest 2020), across 7 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 Implantech Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implantech Associates, Inc. is 71 days. Since 2017: 289 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Implantech Associates, Inc.?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 16); LZK (Implant, Malar, 11); FZE (Prosthesis, Nose, Internal, 7).
Next steps
- See all 41 Implantech Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWP, Implantech Associates, 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.