Compass Universal Hinge
FDA 510(k) K970713 · Smith & Nephew, Inc., Orthopaedic Div.
510(k) numberK970713
Submission
- Device name
- Compass Universal Hinge
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US - Received
- February 27, 1997
- Decision date
- April 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
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|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K991538 | Opera Cupflanged Acetabular ComponentsJDI · Abbreviated | 06/03/1999SE |
| K970635 | Titanium Spinal Rod SystemKWQ · Traditional | 08/14/1997SE |
| K971414 | Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral HeadsLZO · Traditional | 07/16/1997SE |
| K970748 | Taylor Spatial Frame External Fixation SystemKTT · Traditional | 05/09/1997SE |
| K970751 | Heidelberg External FixatorJDW · Traditional | 04/16/1997SE |
| K970351 | Global Taper Spectron Hip StemsJDI · Traditional | 02/28/1997SE |
| K970337 | Ha Global Taper (GT) Tapered Hip StemMEH · Traditional | 02/28/1997SE |
| K963255 | Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial InsertJWH · Traditional | 01/02/1997SN |
| K962784 | Ultium Spinal Plating SystemMNH · Traditional | 10/02/1996SN |
Questions and answers
When was Compass Universal Hinge cleared by the FDA?
Compass Universal Hinge (K970713) received a 510(k) decision of Substantially Equivalent on April 3, 1997, 35 days after the submission was received.
What is the product code of K970713?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.