The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Coated Zt Proximal Sleeve.
Device ID | K934412 |
510k Number | K934412 |
Device Name: | COATED ZT PROXIMAL SLEEVE |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Contact | Kevin J Crossen |
Correspondent | Kevin J Crossen JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-10 |
Decision Date | 1994-06-03 |