510(k) K071173
- Device
- RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
- Applicant
- OSSUR AMERICANS (FORMERLY THE JEROME GROUP)
- 510(k) number
- K071173
- Product code
- HAX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-05-25
- Date received
- 2007-04-27
- Regulation
- 882.5960
- Classification name
- Tong, Skull For Traction
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BERNIE TATRO
- Address
- 1414 Metropolitan Ave. Paulsboro NJ US 08066 08066
FDA Registration Numbers#
- 9611274
- 3004464325
- 2183744
- 2182979
- 1526439
- 1836161
- 8030607
- 3008114965
Source Documents#
Other 510(k) Records For Product Code HAX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090733 | PMT HALO SYSTEM | Pmt Corp. | 2009-07-28 |
| 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 |
Legacy Summary#
summary
FDA Review#
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