Steadman Ligament Graft Passer and Protector
FDA 510(k) K941896 · Depuy, Inc.
510(k) numberK941896
Submission
- Device name
- Steadman Ligament Graft Passer and Protector
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- April 18, 1994
- Decision date
- November 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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Questions and answers
When was Steadman Ligament Graft Passer and Protector cleared by the FDA?
Steadman Ligament Graft Passer and Protector (K941896) received a 510(k) decision of Substantially Equivalent on November 7, 1994, 203 days after the submission was received.
What is the product code of K941896?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.