Washer, Bolt, Nut, Orthopedic
FDA 510(k) K954682 · Linvatec Corp.
510(k) numberK954682
Submission
- Device name
- Washer, Bolt, Nut, Orthopedic
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- October 11, 1995
- Decision date
- February 9, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HTN – Washer, Bolt Nut
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Washer, Bolt, Nut, Orthopedic cleared by the FDA?
Washer, Bolt, Nut, Orthopedic (K954682) received a 510(k) decision of Substantially Equivalent for Some Indications on February 9, 1996, 121 days after the submission was received.
What is the product code of K954682?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.