Splint, Hoake Inflatable Air
FDA 510(k) K781754 · Depuy, Inc.
510(k) numberK781754
Submission
- Device name
- Splint, Hoake Inflatable Air
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- October 17, 1978
- Decision date
- November 8, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQZ – Component, Traction, Non-Invasive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5890
- Specialty
- Orthopedic
Other 510(k)s with product code KQZ
| 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 |
More from Backtrac
| 510(k) | Device | Decision |
|---|---|---|
| K043058 | Pinnacle Constrained Acetabular LinersKWZ · Traditional | 03/14/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | 12/08/2004SE |
| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Splint, Hoake Inflatable Air cleared by the FDA?
Splint, Hoake Inflatable Air (K781754) received a 510(k) decision of Substantially Equivalent on November 8, 1978, 22 days after the submission was received.
What is the product code of K781754?
The FDA product code is KQZ – Component, Traction, Non-Invasive, a Class I (low risk) device regulated under 21 CFR 888.5890.