Pylon Intramedullaary Nail System
FDA 510(k) K992350 · Alphatec Mfg., Inc.
510(k) numberK992350
Submission
- Device name
- Pylon Intramedullaary Nail System
- Applicant
- Alphatec Mfg., Inc.
Palm Desert, CA, US - Received
- July 14, 1999
- Decision date
- September 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K980788 | Alphatec Wire External Fixation SystemJDW · Traditional | 05/22/1998SE |
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Questions and answers
When was Pylon Intramedullaary Nail System cleared by the FDA?
Pylon Intramedullaary Nail System (K992350) received a 510(k) decision of Substantially Equivalent on September 22, 1999, 70 days after the submission was received.
What is the product code of K992350?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.