Plla Pin
FDA 510(k) K010983 · Bionx Implants, Inc.
510(k) numberK010983
Submission
- Device name
- Plla Pin
- Applicant
- Bionx Implants, Inc.
Tampere, FI - Received
- April 2, 2001
- Decision date
- June 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
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More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K030388 | Impact Suture Anchor. Model 433510HWC · Traditional | 04/24/2003SE |
| K023022 | Nugen FX ScrewHWC · Special | 10/04/2002SE |
| K020056 | Duet Suture AnchorHWC · Traditional | 06/26/2002SE |
| K011569 | Biosorbfx O/M 2.0/2/4 SystemJEY · Traditional | 02/22/2002SE |
| K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214HWC · Special | 11/21/2001SE |
| K013057 | Biocuff,C, Models 236018, 236028, 236036MAI · Special | 10/12/2001SE |
| K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116MAI · Special | 09/19/2001SE |
| K012001 | SmartscrewHWC · Special | 07/18/2001SE |
| K012000 | 1.5MM Bone Fixation KitHWC · Special | 07/18/2001SE |
| K010554 | Meniscus Arrow Sheath #CN1000A; Smartscrew Acl Sheath #SSA2000AHWC · Traditional | 05/25/2001SE |
Questions and answers
When was Plla Pin cleared by the FDA?
Plla Pin (K010983) received a 510(k) decision of Substantially Equivalent on June 13, 2001, 72 days after the submission was received.
What is the product code of K010983?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.