Walter Abendschein, M.D.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Walter Abendschein, M.D.” (first 1997, latest 2001), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 101 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Walter Abendschein, M.D. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011603 | VHS PEDIATRIC HIP SCREW SYSTEM | KTT | 2001-08-15 | 83 |
| K002184 | COD COMPRESSION OSTEOTOMY DEVICE | HRS | 2000-11-24 | 128 |
| K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | KRR | 2000-06-23 | 101 |
| K991806 | VHS SUPRACONDYLAR PLATE SYSTEM | KTT | 1999-08-06 | 72 |
| K964880 | VARI-ANGLE HIP SCREW (VHS) SYSTEM | KTT | 1997-10-16 | 315 |
Recalls
openFDA lists no recalls under a recalling firm named Walter Abendschein, M.D..
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.
- Walter Lorenz Surgical, Inc. (56 510(k)s)
- Walter Ansted Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Walter Abendschein, M.D.?
FDA lists 5 510(k) clearances under the applicant name “Walter Abendschein, M.D.” (first 1997, latest 2001), across 3 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 Walter Abendschein, M.D.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Walter Abendschein, M.D. is 101 days.
Which FDA product codes appear under Walter Abendschein, M.D.?
The most frequent FDA product codes under this applicant name are KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3); HRS (Plate, Fixation, Bone, 1); KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, 1).
Next steps
- See all 5 Walter Abendschein, M.D. clearances with predicates and recalls
- Run predicate analysis for product code KTT, Walter Abendschein, M.D.'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.