The following data is part of a premarket notification filed by Depuy Synthes Spine, Inc. with the FDA for Vertical Expandable Prosthetic Titanium Rib.
Device ID | K142587 |
510k Number | K142587 |
Device Name: | Vertical Expandable Prosthetic Titanium Rib |
Classification | Prosthesis, Rib Replacement |
Applicant | Depuy Synthes Spine, Inc. 325 Paramount Drive Raynham, MA 02767 |
Contact | Catherine Kilshaw |
Correspondent | Catherine Kilshaw Depuy Synthes Spine, Inc. 325 Paramount Drive Raynham, MA 02767 |
Product Code | MDI |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-09-15 |
Decision Date | 2014-11-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
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