Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II Ex
FDA 510(k) K102885 · Stryker Corp.
510(k) numberK102885
Submission
- Device name
- Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II Ex
- Applicant
- Stryker Corp.
Mahwah, NJ, US - Received
- September 30, 2010
- Decision date
- January 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEC – Component, Traction, Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II Ex cleared by the FDA?
Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II Ex (K102885) received a 510(k) decision of Substantially Equivalent on January 14, 2011, 106 days after the submission was received.
What is the product code of K102885?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.