Hoffmann II Compact External Fixation System
FDA 510(k) K971755 · Howmedica Corp.
510(k) numberK971755
Submission
- Device name
- Hoffmann II Compact External Fixation System
- Applicant
- Howmedica Corp.
Rutherford, NJ, US - Received
- May 12, 1997
- Decision date
- July 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Compact External Fixation System cleared by the FDA?
Hoffmann II Compact External Fixation System (K971755) received a 510(k) decision of Substantially Equivalent on July 17, 1997, 66 days after the submission was received.
What is the product code of K971755?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.