The following data is part of a premarket notification filed by Link America, Inc. with the FDA for Link, Acetabular Revision Mesh Cup.
| Device ID | K972760 |
| 510k Number | K972760 |
| Device Name: | LINK, ACETABULAR REVISION MESH CUP |
| Classification | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Applicant | LINK AMERICA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart LINK AMERICA, INC. 321 PALMER RD. Denville, NJ 07834 |
| Product Code | JDJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-24 |
| Decision Date | 1997-10-22 |