Hoffman Universal Foot Support
FDA 510(k) K821252 · Howmedica Corp.
510(k) numberK821252
Submission
- Device name
- Hoffman Universal Foot Support
- Applicant
- Howmedica Corp.
Mchenry, IL, US - Received
- April 30, 1982
- Decision date
- June 22, 1982
- 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
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|---|---|---|---|
| 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 |
| K802869 | Backtrac 90-90 TractionKQZ · Traditional | Backtrac | 12/11/1980SE |
| K781754 | Splint, Hoake Inflatable AirKQZ · Traditional | Depuy, Inc. | 11/08/1978SE |
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| K980926 | Duration II Acetabular Components-Ethylene Oxide SterilizationJDI · Traditional | 12/16/1998SE |
| K980925 | Duration II Tibial Inserts-Ethylene Oxide SterilizationJWH · Traditional | 12/16/1998SE |
| K980632 | Duration II Tibial Inserts - Gas Plasma SterilizationJWH · Traditional | 12/11/1998SE |
| K980626 | Duration II Acetabular Components-Gas Plasma SterilizationJDI · Traditional | 12/11/1998SE |
Questions and answers
When was Hoffman Universal Foot Support cleared by the FDA?
Hoffman Universal Foot Support (K821252) received a 510(k) decision of Substantially Equivalent on June 22, 1982, 53 days after the submission was received.
What is the product code of K821252?
The FDA product code is KQZ – Component, Traction, Non-Invasive, a Class I (low risk) device regulated under 21 CFR 888.5890.