FDA Product Code
FDA Product Code HAX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5960
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K090733 | PMT HALO SYSTEM | Pmt Corp. | 2009-07-28 | Traditional | PDF ↗ |
| K071173 | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D | Ossur Americans (Formerly the Jerome Group) | 2007-05-25 | Special | PDF ↗ |
| K051918 | RESOLVE OPEN BACK HALO RINGS | Jerome Medical | 2005-08-17 | Special | PDF ↗ |
| K023959 | JEROME GLASS RING | The Jerome Group, Inc. | 2003-02-21 | Traditional | PDF ↗ |
| K003662 | SPINE WORKS COLLAR | Spine Works | 2001-07-09 | Traditional | PDF ↗ |
| K980689 | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM | Friddle'S Orthopedic Appliances, Inc. | 1999-02-18 | Traditional | PDF ↗ |
| K930021 | J TONGS | Jerome Medical | 1995-12-06 | Traditional | PDF ↗ |
| K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | Ace Medical Co. | 1995-10-12 | Traditional | PDF ↗ |
| K924606 | BREMER IMAGING TONGS-MRI MODEL | Bremer Medical, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | American Threshold Industries, Inc. | 1992-08-17 | Traditional | PDF ↗ |
| K873693 | LEVTECH COMPOSITE TRACTION TONGS | Levtech, Inc. | 1988-02-05 | Traditional | PDF ↗ |
| K871663 | PMT TRACTION TONGS | Progress Mankind Technology | 1987-06-19 | Traditional | PDF ↗ |
| K864746 | BREMER HALO SYSTEM | Bremer Orthopedics | 1986-12-22 | Traditional | PDF ↗ |
| K861470 | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) | Applied Medical Systems | 1986-05-02 | Traditional | PDF ↗ |
| K853066 | MAYFIELD DISPOSABLE SKULL PINS | Codman & Shurtleff, Inc. | 1985-08-08 | Traditional | PDF ↗ |
| K842680 | ACE UNIVERSAL TONG | Buckman Co., Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K834047 | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | Progress Mankind Technology | 1984-02-17 | Traditional | PDF ↗ |
| K822885 | HALO TRACTION CERVICAL IMMOBILIZATION | Orthopedic Systems, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | Ace Orthopedic Manufacturing Co. | 1981-03-20 | Traditional | PDF ↗ |
| K792586 | HALO SUPPORT JACKET & ASSOC. HARDWARE | Depuy, Inc. | 1979-12-31 | Traditional | PDF ↗ |
Product code HAX · Class II · Neurology. Data: openFDA.