Product code KQZ
- Device name
- Component, Traction, Non-Invasive
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.5890
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884132 | TECNOL BUCKS TRACTION W/HEEL PROTECTOR | Technol, Inc. | 1988-10-11 |
| K882640 | TECNOL SECURE-ALL PELVIC TRACTION BELT | Tecnol New Jersey Wound Care, Inc. | 1988-07-27 |
| K871900 | OVER DRAPE LEG HOLDER | Avec Scientific Design Corp. | 1987-06-16 |
| K871296 | T.E.D.(TM) TRACTION DEVICE | The Kendal Co. | 1987-04-15 |
| K854270 | MURPHY ADJUSTABLE SPLINT | Comfortex, Inc. | 1985-12-09 |
| K831002 | TPG 1000 | Physical Diagnostics, Inc. | 1983-06-24 |
| K823660 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-12-30 |
| K823163 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-11-10 |
| K821252 | HOFFMAN UNIVERSAL FOOT SUPPORT | Howmedica Corp. | 1982-06-22 |
| K802869 | BACKTRAC 90-90 TRACTION | Backtrac | 1980-12-11 |
| K781754 | SPLINT, HOAKE INFLATABLE AIR | Depuy, Inc. | 1978-11-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00844107000804 | QuikBow | Arbutus Medical Inc | 2026-04-28 |
| 00848340016806 | ALLEN | HILL-ROM, INC. | 2026-04-24 |
| 00810075281491 | BoneFoam | BONE FOAM, INC. | 2025-08-15 |
| 00810075281521 | BoneFoam | BONE FOAM, INC. | 2025-08-15 |
| 00787551011678 | NS90403 Shoulder Suspension Kit | XODUS MEDICAL, INC. | 2022-12-08 |
| 00787551011654 | 90403 Shoulder Arthroscopy Kit | XODUS MEDICAL, INC. | 2022-12-08 |
| 00810075280821 | BoneFoam | BONE FOAM, INC. | 2022-05-22 |
| 00810075280883 | BoneFoam | BONE FOAM, INC. | 2022-05-22 |
| 00842430112508 | FINGER TRAPS, 5 MEDIUM, LITEGRIP | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 2021-08-25 |
| 00842430112515 | FINGER TRAPS, 5 SMALL, LITEGRIP | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 2021-08-25 |
| 00842430112522 | FINGER TRAPS, 5 EXTRA SMALL, LITEGRIP | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 2021-08-25 |
| 00842430112492 | FINGER TRAPS, 5 LARGE, LITEGRIP | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 2021-02-03 |
| 00850016589040 | Top Shelf Orthopedics | Top Shelf Manufacturing, LLC | 2020-12-18 |
| 00850016589033 | Top Shelf Orthopedics | Top Shelf Manufacturing, LLC | 2020-12-18 |
| 00850016589026 | Top Shelf Orthopedics | Top Shelf Manufacturing, LLC | 2020-12-18 |
| 00850016589019 | Top Shelf Orthopedics | Top Shelf Manufacturing, LLC | 2020-12-18 |
| 00885556714119 | ACUFEX | Smith & Nephew, Inc. | 2018-11-16 |
| 00885556714126 | ACUFEX | Smith & Nephew, Inc. | 2018-11-16 |
| 00888867019942 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 00888867019973 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 00888867019980 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 00888867019997 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 00888867020009 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 00888867020016 | Arthrex® | ARTHREX, INC. | 2018-08-03 |
| 00880304406414 | LEG POSITIONER PAD, 2 PK | Biomet Orthopedics, LLC | 2017-08-04 |
| 00880304406353 | LEG POSITIONER | Biomet Orthopedics, LLC | 2017-07-28 |
| 00880304406391 | BI-LATERAL KNEE ATTACHMENT | Biomet Orthopedics, LLC | 2017-07-28 |
| 00880304406421 | PADDLE, LEG POSITIONER, RIGHT | Biomet Orthopedics, LLC | 2017-07-28 |
| 00880304406438 | PADDLE, LEG POSITIONER, LEFT | Biomet Orthopedics, LLC | 2017-07-28 |
| 00885554023473 | N/A | Smith & Nephew, Inc. | 2016-04-12 |