The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Periarticular Plating System.
Device ID | K042237 |
510k Number | K042237 |
Device Name: | EBI PERIARTICULAR PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
Contact | Peter Allan |
Correspondent | Peter Allan EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-18 |
Decision Date | 2004-09-16 |
Summary: | summary |