Nancy Nail
FDA 510(k) K960642 · Landos, Inc.
510(k) numberK960642
Submission
- Device name
- Nancy Nail
- Applicant
- Landos, Inc.
Malvern, PA, US - Received
- February 14, 1996
- Decision date
- May 17, 1996
- 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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| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K964226 | Memory Staple (20 Sizes Available)JDR · Traditional | 08/05/1997SE |
| K971070 | Scarf Thread-Head (TM) Head ScrewHWC · Traditional | 07/09/1997SE |
| K971069 | Twist-Off (TM) ScrewHWC · Traditional | 07/09/1997SE |
| K971068 | 34MM Scarf Thread-Head(Tm) ScrewHWC · Traditional | 07/09/1997SE |
| K961732 | KarMEH · Traditional | 07/08/1997SE |
| K970846 | 22.2/+4MM Co CR & Zirconia Femoral HeadLZO · Traditional | 06/05/1997SN |
| K953111 | CorailLZO · Traditional | 12/27/1996SE |
| K962233 | Twist-Off ScrewHWC · Traditional | 10/03/1996SE |
| K962236 | Scarf Thread-Head ScrewHWC · Traditional | 09/20/1996SE |
| K943727 | Biostop G Bone Cement RestrictorLZN · Traditional | 05/11/1995SE |
Questions and answers
When was Nancy Nail cleared by the FDA?
Nancy Nail (K960642) received a 510(k) decision of Substantially Equivalent on May 17, 1996, 93 days after the submission was received.
What is the product code of K960642?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.