3D-SPINE
FDA 510(k) K962377 · Skill Technologies, Inc.
510(k) numberK962377
Submission
- Device name
- 3D-SPINE
- Applicant
- Skill Technologies, Inc.
Phoenix, AZ, US - Received
- June 20, 1996
- Decision date
- September 3, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQX – Goniometer, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1500
- Specialty
- Orthopedic
Other 510(k)s with product code KQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011827 | Ortelius 800KQX · Traditional | Orthoscan , Ltd. | 08/28/2001SE |
| K971079 | Interlogics W-Tracker and Wrist Works SoftwareKQX · Traditional | Interlogics, Inc. | 07/09/1997SE |
| K961212 | Spinal TouchKQX · Traditional | Fasstech | 06/12/1996SE |
| K954647 | InclinometerKQX · Traditional | J-Tech, Inc. | 10/30/1995SE |
| K943929 | Dataglove and Movement Analysis System (Mas)KQX · Traditional | Greenleaf Medical Systems, Inc. | 05/15/1995SE |
| K945630 | Large Muscle Strength GaugeKQX · Traditional | J-Tech, Inc. | 05/10/1995SE |
| K943898 | Saunders Electronic InclinometerKQX · Traditional | The Saunders Group | 11/28/1994SE |
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | Andronic Devices, Ltd. | 11/21/1994SE |
| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | Baltimore Therapeutic Equipment Co. | 06/27/1994SE |
| K933063 | Isotechnologies Back Tracker and Back Works SoftwaKQX · Traditional | Isotechnologies, Inc. | 01/27/1994SE |
Questions and answers
When was 3D-SPINE cleared by the FDA?
3D-SPINE (K962377) received a 510(k) decision of Substantially Equivalent on September 3, 1996, 75 days after the submission was received.
What is the product code of K962377?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.