Depuy Motech Peak Fixation System
FDA 510(k) K963350 · Depuy, Inc.
510(k) numberK963350
Submission
- Device name
- Depuy Motech Peak Fixation System
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- August 26, 1996
- Decision date
- November 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
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Questions and answers
When was Depuy Motech Peak Fixation System cleared by the FDA?
Depuy Motech Peak Fixation System (K963350) received a 510(k) decision of Substantially Equivalent on November 14, 1996, 80 days after the submission was received.
What is the product code of K963350?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.