Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw
FDA 510(k) K981670 · Depuy, Inc.
510(k) numberK981670
Submission
- Device name
- Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- May 12, 1998
- Decision date
- June 22, 1998
- 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 Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw cleared by the FDA?
Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw (K981670) received a 510(k) decision of Substantially Equivalent on June 22, 1998, 41 days after the submission was received.
What is the product code of K981670?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.