Polarus Cap Screw
FDA 510(k) K013616 · Acu Med, Inc.
510(k) numberK013616
Submission
- Device name
- Polarus Cap Screw
- Applicant
- Acu Med, Inc.
Beaverton, OR, US - Received
- November 5, 2001
- Decision date
- December 19, 2001
- 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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| K964500 | Acumed Tension Band PinHTY · Traditional | 12/09/1996SE |
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Questions and answers
When was Polarus Cap Screw cleared by the FDA?
Polarus Cap Screw (K013616) received a 510(k) decision of Substantially Equivalent on December 19, 2001, 44 days after the submission was received.
What is the product code of K013616?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.