The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for As20 Composite Graft.
Device ID | K141746 |
510k Number | K141746 |
Device Name: | AS20 COMPOSITE GRAFT |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road -- Memphis, TN 38111 |
Contact | Leslie Fitch |
Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road -- Memphis, TN 38111 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-30 |
Decision Date | 2014-08-04 |
Summary: | summary |