D.T.T. Lock Screw Inserter
FDA 510(k) K790941 · Depuy, Inc.
510(k) numberK790941
Submission
- Device name
- D.T.T. Lock Screw Inserter
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- May 18, 1979
- Decision date
- May 23, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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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 D.T.T. Lock Screw Inserter cleared by the FDA?
D.T.T. Lock Screw Inserter (K790941) received a 510(k) decision of Substantially Equivalent on May 23, 1979, 5 days after the submission was received.
What is the product code of K790941?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.