Ip-Xs Compression Nail System
FDA 510(k) K032548 · Plus Orthopedics
510(k) numberK032548
Submission
- Device name
- Ip-Xs Compression Nail System
- Applicant
- Plus Orthopedics
Round Rock, TX, US - Received
- August 18, 2003
- Decision date
- September 10, 2003
- 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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| K033763 | Modification to Slim Gliding Nail SystemKTT · Special | 12/18/2003SE |
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Questions and answers
When was Ip-Xs Compression Nail System cleared by the FDA?
Ip-Xs Compression Nail System (K032548) received a 510(k) decision of Substantially Equivalent on September 10, 2003, 23 days after the submission was received.
What is the product code of K032548?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.