Depuy Low Profile Bone Screw
FDA 510(k) K970929 · Depuy, Inc.
510(k) numberK970929
Submission
- Device name
- Depuy Low Profile Bone Screw
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- March 13, 1997
- Decision date
- June 9, 1997
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
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| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
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Questions and answers
When was Depuy Low Profile Bone Screw cleared by the FDA?
Depuy Low Profile Bone Screw (K970929) received a 510(k) decision of Substantially Equivalent for Some Indications on June 9, 1997, 88 days after the submission was received.
What is the product code of K970929?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.