Component, Traction, Non-Invasive
FDA product code KQZ · Class I (low risk) · 21 CFR 888.5890 · Orthopedic
11510(k) clearances
0PMA approvals
9recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884132 | Tecnol Bucks Traction W/Heel ProtectorKQZ · Traditional | Technol, Inc. | 10/11/1988SE |
| K882640 | Tecnol Secure-All Pelvic Traction BeltKQZ · Traditional | Tecnol New Jersey Wound Care, Inc. | 07/27/1988SE |
| K871900 | Over Drape Leg HolderKQZ · Traditional | Avec Scientific Design Corp. | 06/16/1987SE |
| K871296 | T.E.D.(Tm) Traction DeviceKQZ · Traditional | The Kendal Co. | 04/15/1987SE |
| K854270 | Murphy Adjustable SplintKQZ · Traditional | Comfortex, Inc. | 12/09/1985SE |
| K831002 | TPG 1000KQZ · Traditional | Physical Diagnostics, Inc. | 06/24/1983SE |
| K823660 | Universal Bucks TractionKQZ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823163 | Universal Bucks TractionKQZ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K821252 | Hoffman Universal Foot SupportKQZ · Traditional | Howmedica Corp. | 06/22/1982SE |
| K802869 | Backtrac 90-90 TractionKQZ · Traditional | Backtrac | 12/11/1980SE |
| K781754 | Splint, Hoake Inflatable AirKQZ · Traditional | Depuy, Inc. | 11/08/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0635-2022 Class II | Acufex Access Advanced Positioning Kit - indicated for use to position and distract the…Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did… | Smith & Nephew, Inc. | 12/14/2021Open, Classified |
| Z-1004-2019 Class II | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL…Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR… | Ossur Americas | 06/21/2018Terminated |
| Z-1003-2019 Class II | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel…Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR… | Ossur Americas | 06/21/2018Terminated |
| Z-1515-2016 Class II | Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Ossur H / F | 03/14/2016Terminated |
| Z-1514-2016 Class II | Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Ossur H / F | 03/14/2016Terminated |
| Z-1513-2016 Class II | Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Ossur H / F | 03/14/2016Terminated |
| Z-1512-2016 Class II | Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Ossur H / F | 03/14/2016Terminated |
| Z-1511-2016 Class II | Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structure used with…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Ossur H / F | 03/14/2016Terminated |
| Z-1510-2016 Class II | Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the…There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. | Ossur H / F | 03/14/2016Terminated |