HAX — Tong, Skull For Traction Class II
FDA product code HAX covers "Tong, Skull For Traction", a Class II medical device regulated under 21 CFR 882.5960. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HAX
- Device Class
- Class II
- Regulation Number
- 882.5960
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K090733 | pmt | PMT HALO SYSTEM | July 28, 2009 |
| K071173 | ossur americans (formerly the jerome group) | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D | May 25, 2007 |
| K051918 | jerome medical | RESOLVE OPEN BACK HALO RINGS | August 17, 2005 |
| K023959 | jerome group | JEROME GLASS RING | February 21, 2003 |
| K003662 | spine works | SPINE WORKS COLLAR | July 9, 2001 |
| K980689 | friddle orthopedic appliances | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM | February 18, 1999 |
| K930021 | jerome medical | J TONGS | December 6, 1995 |
| K954069 | ace medical | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | October 12, 1995 |
| K924606 | bremer medical | BREMER IMAGING TONGS-MRI MODEL | September 9, 1993 |
| K915530 | american threshold industries | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | August 17, 1992 |
| K873693 | levtech | LEVTECH COMPOSITE TRACTION TONGS | February 5, 1988 |
| K871663 | progress mankind technology | PMT TRACTION TONGS | June 19, 1987 |
| K864746 | bremer orthopedics | BREMER HALO SYSTEM | December 22, 1986 |
| K861470 | applied medical systems | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) | May 2, 1986 |
| K853066 | codman and shurtleff | MAYFIELD DISPOSABLE SKULL PINS | August 8, 1985 |
| K842680 | buckman co | ACE UNIVERSAL TONG | September 4, 1984 |
| K834047 | progress mankind technology | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | February 17, 1984 |
| K822885 | orthopedic systems | HALO TRACTION CERVICAL IMMOBILIZATION | November 22, 1982 |
| K810193 | ace orthopedic manufacturing | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | March 20, 1981 |
| K792586 | depuy | HALO SUPPORT JACKET & ASSOC. HARDWARE | December 31, 1979 |