RESOLVE OPEN BACK HALO RINGS
FDA 510(k) clearance K051918 · decided 2005-08-17
Clearance details
- K-number
- K051918
- Device name
- RESOLVE OPEN BACK HALO RINGS
- Applicant
- Jerome Medical
- Decision
- Substantially Equivalent
- Date received
- 2005-07-15
- Decision date
- 2005-08-17
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- HAX
- Device class
- 2
- Regulation number
- 882.5960
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Moorestown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PMT HALO SYSTEM (K090733) | Pmt Corp. | 2009-07-28 |
| RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (K071173) | Ossur Americans (Formerly the Jerome Group) | 2007-05-25 |
| JEROME GLASS RING (K023959) | The Jerome Group, Inc. | 2003-02-21 |
| SPINE WORKS COLLAR (K003662) | Spine Works | 2001-07-09 |
| FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (K980689) | Friddle'S Orthopedic Appliances, Inc. | 1999-02-18 |
| J TONGS (K930021) | Jerome Medical | 1995-12-06 |
| ACE CERVICAL TRACTION HALOZS, TONGS & PINS (K954069) | Ace Medical Co. | 1995-10-12 |
| BREMER IMAGING TONGS-MRI MODEL (K924606) | Bremer Medical, Inc. | 1993-09-09 |
| NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE (K915530) | American Threshold Industries, Inc. | 1992-08-17 |
| LEVTECH COMPOSITE TRACTION TONGS (K873693) | Levtech, Inc. | 1988-02-05 |
| PMT TRACTION TONGS (K871663) | Progress Mankind Technology | 1987-06-19 |
| BREMER HALO SYSTEM (K864746) | Bremer Orthopedics | 1986-12-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixat recall (Z-1507-2009) | Ossur Engineering, Inc | 2009-06-19 |
| ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixat recall (Z-1508-2009) | Ossur Engineering, Inc | 2009-06-19 |
| ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a fixat recall (Z-1509-2009) | Ossur Engineering, Inc | 2009-06-19 |