Pin Set, Bone Rush, 7-1/4 Thru 18-1/2 Inches Long
FDA 510(k) K852563 · The Huxley Instrument Corp.
510(k) numberK852563
Submission
- Device name
- Pin Set, Bone Rush, 7-1/4 Thru 18-1/2 Inches Long
- Applicant
- The Huxley Instrument Corp.
Penn Yan, NY, US - Received
- June 17, 1985
- Decision date
- June 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| 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 |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K852721 | Bozeman Uterine Forceps, Straight, 10+410 0R 420HCZ · Traditional | 09/06/1985SE |
| K853016 | Stille Angular Rongeur, 8-3/4 SS 410 · Traditional | 08/07/1985SE |
| K852993 | Bone Rongeurs · Traditional | 08/07/1985SE |
| K853015 | Self-Centering Bone Holding Forceps, 10-1/4 SS420GEN · Traditional | 07/29/1985SE |
| K852716 | Taylor Percussion Hammer SS 410 or 420GWZ · Traditional | 07/26/1985SE |
| K852735 | Scalpel Handle #7 SS 410 or 420GDZ · Traditional | 07/15/1985SE |
| K852734 | O.R. Scissors, Straight, 5-1/2+SHP/SHP SS · Traditional | 07/15/1985SE |
| K852732 | Iris Scissors, Curved, 4-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852731 | Lister Bandage Scissors, 5-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852730 | Crile Forceps, Striaght, 6-1/4+SS 410 or 420GEN · Traditional | 07/15/1985SE |
Questions and answers
When was Pin Set, Bone Rush, 7-1/4 Thru 18-1/2 Inches Long cleared by the FDA?
Pin Set, Bone Rush, 7-1/4 Thru 18-1/2 Inches Long (K852563) received a 510(k) decision of Substantially Equivalent on June 28, 1985, 11 days after the submission was received.
What is the product code of K852563?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.