| Device Type ID | 3813 |
| Device Name | Apparatus, Traction, Non-powered |
| Regulation Description | Nonpowered Orthopedic Traction Apparatus And Accessories. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.5850 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HST |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3813 |
| Device | Apparatus, Traction, Non-powered |
| Product Code | HST |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonpowered Orthopedic Traction Apparatus And Accessories. |
| CFR Regulation Number | 888.5850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STL INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STL INTL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 14 |
Adverse Event Without Identified Device Or Use Problem | 9 |
Break | 9 |
Fitting Problem | 8 |
Failure To Adhere Or Bond | 7 |
Detachment Of Device Component | 6 |
Mechanical Jam | 6 |
Failure To Align | 4 |
Difficult To Advance | 3 |
Sticking | 3 |
Device-Device Incompatibility | 2 |
Material Twisted / Bent | 2 |
Fracture | 2 |
Bent | 1 |
Disassembly | 1 |
Device Dislodged Or Dislocated | 1 |
Unintended Movement | 1 |
Device Issue | 1 |
Separation Failure | 1 |
Mechanics Altered | 1 |
Loose Or Intermittent Connection | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 84 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Allen Medical Systems, Inc. | II | Feb-14-2017 |
| 2 | Allen Medical Systems, Inc. | II | Dec-29-2016 |
| 3 | Dick's Sporting Goods | II | Jan-20-2015 |
| 4 | Implantech Associates Inc | II | Feb-20-2014 |