Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Walter Abendschein, M.D. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
315 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011603 | VHS PEDIATRIC HIP SCREW SYSTEM | Walter Abendschein, M.D. | 2001-08-15 | 83 | 2 |
| K002184 | COD COMPRESSION OSTEOTOMY DEVICE | Walter Abendschein, M.D. | 2000-11-24 | 128 | 0 |
| K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | Walter Abendschein, M.D. | 2000-06-23 | 101 | 0 |
| K991806 | VHS SUPRACONDYLAR PLATE SYSTEM | Walter Abendschein, M.D. | 1999-08-06 | 72 | 0 |
| K964880 | VARI-ANGLE HIP SCREW (VHS) SYSTEM | Walter Abendschein, M.D. | 1997-10-16 | 315 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda