Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinal Specialties, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
420 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960100 | SPINAL SPECIALTIES NERVE BLOCK TRAY | Spinal Specialties, Inc. | 1996-04-24 | 104 | 0 |
| K960082 | DISCOGRAPHY KIT | Spinal Specialties, Inc. | 1996-03-21 | 70 | 0 |
| K942863 | EPIDURAL NEEDLE | Spinal Specialties, Inc. | 1995-08-11 | 420 | 0 |
| K944029 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | Spinal Specialties, Inc. | 1995-06-30 | 317 | 0 |
| K943319 | GERTIE MARX EPI-SPINAL TRAY | Spinal Specialties, Inc. | 1995-06-30 | 354 | 0 |
| K950820 | SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE | Spinal Specialties, Inc. | 1995-06-30 | 127 | 0 |
| K941343 | SPINAL ANESTHESIA TRAY | Spinal Specialties, Inc. | 1994-08-11 | 143 | 0 |
| K935245 | EPIDURAL ANESTHESIA TRAY | Spinal Specialties, Inc. | 1994-05-02 | 182 | 0 |
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