Biofix* Biodegradable Fixation Rod
FDA 510(k) K890902 · Davis & Geck, Inc.
510(k) numberK890902
Submission
- Device name
- Biofix* Biodegradable Fixation Rod
- Applicant
- Davis & Geck, Inc.
Danbury, CT, US - Received
- February 22, 1989
- Decision date
- November 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Biofix* Biodegradable Fixation Rod cleared by the FDA?
Biofix* Biodegradable Fixation Rod (K890902) received a 510(k) decision of Substantially Equivalent on November 3, 1989, 254 days after the submission was received.
What is the product code of K890902?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.