Powergrip(Tm) Compression Fixation Device
FDA 510(k) K950009 · Synvasive Technology, Inc.
510(k) numberK950009
Submission
- Device name
- Powergrip(Tm) Compression Fixation Device
- Applicant
- Synvasive Technology, Inc.
Rancho Cordova, CA, US - Received
- January 3, 1995
- Decision date
- August 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K093046 | Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX(5 Models, Different SizesONN · Traditional | 03/22/2011SE |
| K070108 | Elibra Dynamic Knee BalancerONN · Traditional | 04/04/2007SE |
| K972508 | Surgical Burs and Surgical Drill BitsHWE · Traditional | 08/26/1997SE |
| K961522 | Kirschner Wire (K-Wire) and Steinmann PinHTY · Traditional | 09/23/1996SE |
| K934336 | SpinalplaneHSZ · Traditional | 03/10/1995SN |
| K933933 | CeboplaneHTZ · Traditional | 04/15/1994SE |
| K930573 | Synvasive Ceramic Sutting BlockLXI · Traditional | 04/07/1994SE |
| K932869 | ArthroplaneHRX · Traditional | 03/25/1994SE |
| K931737 | Hedleyl Intramedullary Preparation BrushHTZ · Traditional | 01/07/1994SE |
Questions and answers
When was Powergrip(Tm) Compression Fixation Device cleared by the FDA?
Powergrip(Tm) Compression Fixation Device (K950009) received a 510(k) decision of Substantially Equivalent on August 18, 1995, 227 days after the submission was received.
What is the product code of K950009?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.