Porocoat New Jersey Shoulder Replacement Sys
FDA 510(k) K844415 · Depuy, Inc.
510(k) numberK844415
Submission
- Device name
- Porocoat New Jersey Shoulder Replacement Sys
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- November 14, 1984
- Decision date
- January 23, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3670
- Specialty
- Orthopedic
- Implant
- Yes
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| K222427 | PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 10/06/2022SE |
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Questions and answers
When was Porocoat New Jersey Shoulder Replacement Sys cleared by the FDA?
Porocoat New Jersey Shoulder Replacement Sys (K844415) received a 510(k) decision of Substantially Equivalent on January 23, 1985, 70 days after the submission was received.
What is the product code of K844415?
The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.