Product code HAX
- Device name
- Tong, Skull For Traction
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5960
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090733 | PMT HALO SYSTEM | Pmt Corp. | 2009-07-28 |
| K071173 | RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D | Ossur Americans (Formerly the Jerome Group) | 2007-05-25 |
| K051918 | RESOLVE OPEN BACK HALO RINGS | Jerome Medical | 2005-08-17 |
| K023959 | JEROME GLASS RING | The Jerome Group, Inc. | 2003-02-21 |
| K003662 | SPINE WORKS COLLAR | Spine Works | 2001-07-09 |
| K980689 | FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM | Friddle'S Orthopedic Appliances, Inc. | 1999-02-18 |
| K930021 | J TONGS | Jerome Medical | 1995-12-06 |
| K954069 | ACE CERVICAL TRACTION HALOZS, TONGS & PINS | Ace Medical Co. | 1995-10-12 |
| K924606 | BREMER IMAGING TONGS-MRI MODEL | Bremer Medical, Inc. | 1993-09-09 |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | American Threshold Industries, Inc. | 1992-08-17 |
| K873693 | LEVTECH COMPOSITE TRACTION TONGS | Levtech, Inc. | 1988-02-05 |
| K871663 | PMT TRACTION TONGS | Progress Mankind Technology | 1987-06-19 |
| K864746 | BREMER HALO SYSTEM | Bremer Orthopedics | 1986-12-22 |
| K861470 | #CTO 100 (CERVICAL TRACTION ORTHOSIS 100) | Applied Medical Systems | 1986-05-02 |
| K853066 | MAYFIELD DISPOSABLE SKULL PINS | Codman & Shurtleff, Inc. | 1985-08-08 |
| K842680 | ACE UNIVERSAL TONG | Buckman Co., Inc. | 1984-09-04 |
| K834047 | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | Progress Mankind Technology | 1984-02-17 |
| K822885 | HALO TRACTION CERVICAL IMMOBILIZATION | Orthopedic Systems, Inc. | 1982-11-22 |
| K810193 | TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG | Ace Orthopedic Manufacturing Co. | 1981-03-20 |
| K792586 | HALO SUPPORT JACKET & ASSOC. HARDWARE | Depuy, Inc. | 1979-12-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00650551042006 | HALO RING | PMT CORPORATION | 2025-03-10 |
| 00650551004790 | HALO RING | PMT CORPORATION | 2025-03-10 |
| 00650551004424 | HALO RING | PMT CORPORATION | 2025-03-10 |
| 00650551004417 | HALO TRAUMA KIT | PMT CORPORATION | 2025-03-10 |
| 00650551003861 | HALO TRAUMA KIT | PMT CORPORATION | 2025-03-10 |
| 10650551093043 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-15 |
| 10650551093050 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-15 |
| 10650551093067 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-15 |
| 10650551093074 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-15 |
| 10650551094255 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-15 |
| 10650551094248 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-15 |
| 10650551093845 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-12 |
| 10650551045820 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-12 |
| 10650551093319 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-11 |
| 00650551044499 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-11 |
| 10650551093920 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-11 |
| 10650551093609 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-11 |
| 10650551093302 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-11 |
| 10650551093296 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-11 |
| 10650551093128 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-10 |
| 10650551093111 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-10 |
| 10650551093104 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-10 |
| 10650551093098 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-10 |
| 10650551093081 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-10 |
| 10650551093036 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-09 |
| 10650551093029 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-09 |
| 10650551093012 | PMT® CORPORATION HALO | PMT CORPORATION | 2018-01-09 |
| 10705034000022 | BREMER | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034000039 | BREMER | DEPUY SPINE, LLC | 2016-06-30 |
| 10705034000046 | NA | DEPUY SPINE, LLC | 2016-06-30 |