Interlocking Intramedullary Nails
FDA 510(k) K884610 · Depuy, Inc.
510(k) numberK884610
Submission
- Device name
- Interlocking Intramedullary Nails
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- November 4, 1988
- Decision date
- December 1, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Interlocking Intramedullary Nails cleared by the FDA?
Interlocking Intramedullary Nails (K884610) received a 510(k) decision of Substantially Equivalent on December 1, 1988, 27 days after the submission was received.
What is the product code of K884610?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.