Joint Measurement Indicator
FDA 510(k) K861264 · Devcom, Inc.
510(k) numberK861264
Submission
- Device name
- Joint Measurement Indicator
- Applicant
- Devcom, Inc.
King Of Prussia, PA, US - Received
- April 4, 1986
- Decision date
- April 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3320
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional | Zimmer, Inc. | 08/07/2008SE |
| K070785 | Dynasty Acetabular SystemJDL · Special | Wrightmedicaltechnologyinc | 07/11/2007SE |
| K061844 | Dynasty Acetabular Shell and Cocr Acetabular LinerJDL · Special | Wrightmedicaltechnologyinc | 12/06/2006SE |
| K051995 | Profemur Renaissance Hip StemJDL · Special | Wrightmedicaltechnologyinc | 08/22/2005SE |
| K051348 | Conserve Total Femoral HeadJDL · Traditional | Wrightmedicaltechnologyinc | 08/19/2005SE |
| K042841 | M2A/C2A Acetabular SystemJDL · Traditional | Biomet, Inc. | 12/21/2004SE |
| K041586 | Profemur S Hip StemJDL · Special | Wrightmedicaltechnologyinc | 07/09/2004SE |
| K041114 | Profemur Tapered Hip StemJDL · Special | Wrightmedicaltechnologyinc | 05/28/2004SE |
| K004043 | Metal Transcend Articulation SystemJDL · Abbreviated | Wrightmedicaltechnologyinc | 07/13/2001SE |
| K950542 | Metal Backed Acetabular ComponentJDL · Traditional | Encore Orthopedics, Inc. | 05/25/1995SE |
More from Encore Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902378 | Cardiothoracic RulerKPR · Traditional | 06/14/1990SE |
| K874233 | Blood Pressure Sleeve W/TubingDXQ · Traditional | 03/22/1988SE |
| K863313 | Grip Strength Device (GSD)IKK · Traditional | 09/09/1986SE |
| K861043 | Spinal Excursion Meter · Traditional | 03/28/1986SE |
| K850021 | Electrocardiograph-Ecg CaliperDPS · Traditional | 02/08/1985SE |
Questions and answers
When was Joint Measurement Indicator cleared by the FDA?
Joint Measurement Indicator (K861264) received a 510(k) decision of Substantially Equivalent on April 15, 1986, 11 days after the submission was received.
What is the product code of K861264?
The FDA product code is JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3320.