Tong, Skull For Traction
Regulation 882.5960
0510(k)s in 12 months (20 all time)
0recalls in 12 months (13 all time)
7recalls that name a 510(k)
Top companies in HAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Instrumed International, Inc. | 0 | 6 |
| Ossur Americas | 0 | 4 |
| Ossur Engineering, Inc | 0 | 3 |
| Jerome Medical | 2 | 0 |
| Progress Mankind Technology | 2 | 0 |
| Ace Medical Co. | 1 | 0 |
| Ace Orthopedic Manufacturing Co. | 1 | 0 |
| American Threshold Industries, Inc. | 1 | 0 |
| Applied Medical Systems | 1 | 0 |
| Bremer Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 28, 2009 | K090733 | PMT HALO SYSTEM Pmt Corp. | HAX |
| May 25, 2007 | K071173 | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D Ossur Americans (Formerly the Jerome Group) | HAX |
| Aug 17, 2005 | K051918 | RESOLVE OPEN BACK HALO RINGS Jerome Medical | HAX |
| Feb 21, 2003 | K023959 | JEROME GLASS RING The Jerome Group, Inc. | HAX |
| Jul 9, 2001 | K003662 | SPINE WORKS COLLAR Spine Works | HAX |
| Feb 18, 1999 | K980689 | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM Friddle'S Orthopedic Appliances, Inc. | HAX |
| Dec 6, 1995 | K930021 | J TONGS Jerome Medical | HAX |
| Oct 12, 1995 | K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS Ace Medical Co. | HAX |
| Sep 9, 1993 | K924606 | BREMER IMAGING TONGS-MRI MODEL Bremer Medical, Inc. | HAX |
| Aug 17, 1992 | K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE American Threshold Industries, Inc. | HAX |
| Feb 5, 1988 | K873693 | LEVTECH COMPOSITE TRACTION TONGS Levtech, Inc. | HAX |
| Jun 19, 1987 | K871663 | PMT TRACTION TONGS Progress Mankind Technology | HAX |
| Dec 22, 1986 | K864746 | BREMER HALO SYSTEM Bremer Orthopedics | HAX |
| May 2, 1986 | K861470 | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) Applied Medical Systems | HAX |
| Aug 8, 1985 | K853066 | MAYFIELD DISPOSABLE SKULL PINS Codman & Shurtleff, Inc. | HAX |
| Sep 4, 1984 | K842680 | ACE UNIVERSAL TONG Buckman Co., Inc. | HAX |
| Feb 17, 1984 | K834047 | PMT-HALO/ORTHOPEDIC JACKET SYSTEM Progress Mankind Technology | HAX |
| Nov 22, 1982 | K822885 | HALO TRACTION CERVICAL IMMOBILIZATION Orthopedic Systems, Inc. | HAX |
| Mar 20, 1981 | K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG Ace Orthopedic Manufacturing Co. | HAX |
| Dec 31, 1979 | K792586 | HALO SUPPORT JACKET & ASSOC. HARDWARE Depuy, Inc. | HAX |
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