The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Gripper Ii Acetabular Cup.
Device ID | K893584 |
510k Number | K893584 |
Device Name: | GRIPPER II ACETABULAR CUP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Contact | Debra L Bing |
Correspondent | Debra L Bing JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
Product Code | LWJ |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-09 |
Decision Date | 1989-07-28 |