ILZ
15 FDA 510(k) clearances · Product code
43 daysmedian time to decision
96 days90th percentile
15clearances measured
FDA profile
- Official device name
- Accessories, Traction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5925
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2005: 6 · 2006: 2 · 2007: 4 · 2008: 11 · 2009: 5 · 2010: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FLEXION DISTRATION SUPPORT (K921711) | Altoona Medical Supply | 1992-07-13 |
| VIBRA-TRAC TRACTION TABLE (K895382) | Vibra-Trac Industries | 1989-10-16 |
| AMX-110, AMX-II AND AMX-III (K884340) | Dyna-Med | 1989-01-24 |
| VECTOR BAR SUSPENSION/TRACTION UNIT (K852398) | Powlan Manufacturing Co. | 1985-08-12 |
| TRACTION ACCESSORIES (K844490) | Jerome Medical | 1985-02-21 |
| SAUNDERS #7080 CERVICAL TRACTION SYS (K831135) | Chattanooga Group, Inc. | 1983-06-24 |
| HEAD HALTER (K830245) | Warm & Form, Orthopedic Materials | 1983-03-09 |
| PELVIC TRACTION BELT (K823659) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| PELVIC TRACTION BELT (K823166) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| BOGER AUTO-TRACTION DEVICE (K820663) | D.C. Medical Device, Inc. | 1982-05-03 |
| CERVI-TRAC (K791808) | Dr. K.G. Rude | 1979-10-01 |
| BANDAGE SPREADER BLOCK (K780227) | Biomet, Inc. | 1978-03-15 |
| TRACTION BELT, PELVIC (K780234) | Biomet, Inc. | 1978-02-23 |
| SPREADER BARS (K780226) | Biomet, Inc. | 1978-02-17 |
| TRACTION HARNESS (K770607) | Will Ross Co. | 1977-04-08 |
Track ILZ automatically
Every clearance here is in the API, with alerts when new ones post.