Modification to Synthes (USA) Polypin
FDA 510(k) K003527 · Synthes (Usa)
510(k) numberK003527
Submission
- Device name
- Modification to Synthes (USA) Polypin
- Applicant
- Synthes (Usa)
Paoli, PA, US - Received
- November 16, 2000
- Decision date
- April 9, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
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Questions and answers
When was Modification to Synthes (USA) Polypin cleared by the FDA?
Modification to Synthes (USA) Polypin (K003527) received a 510(k) decision of Substantially Equivalent on April 9, 2001, 144 days after the submission was received.
What is the product code of K003527?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.