Depuy Rockwood Clavicle Pin
FDA 510(k) K991649 · Depuy, Inc.
510(k) numberK991649
Submission
- Device name
- Depuy Rockwood Clavicle Pin
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- May 13, 1999
- Decision date
- July 14, 1999
- 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
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| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
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| 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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Questions and answers
When was Depuy Rockwood Clavicle Pin cleared by the FDA?
Depuy Rockwood Clavicle Pin (K991649) received a 510(k) decision of Substantially Equivalent on July 14, 1999, 62 days after the submission was received.
What is the product code of K991649?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.