Ace Orthopaedic Washers
FDA 510(k) K895107 · Buckman Co., Inc.
510(k) numberK895107
Submission
- Device name
- Ace Orthopaedic Washers
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- August 15, 1989
- Decision date
- September 11, 1989
- Decision
- Substantially Equivalent (SESE)
- 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 Ace Orthopaedic Washers cleared by the FDA?
Ace Orthopaedic Washers (K895107) received a 510(k) decision of Substantially Equivalent on September 11, 1989, 27 days after the submission was received.
What is the product code of K895107?
The FDA product code is HTN – Washer, Bolt Nut, a Class II (moderate risk) device regulated under 21 CFR 888.3030.