The following data is part of a premarket notification filed by Implex Corp. with the FDA for Hedrocel Acetabular Restrictor.
| Device ID | K962468 |
| 510k Number | K962468 |
| Device Name: | HEDROCEL ACETABULAR RESTRICTOR |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Contact | Gary J Sfeir |
| Correspondent | Gary J Sfeir IMPLEX CORP. 1700 ROCKVILLE PIKE SUITE 450 Rockville, MD 20852 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-25 |
| Decision Date | 1997-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024306240 | K962468 | 000 |
| 00889024306233 | K962468 | 000 |
| 00889024306226 | K962468 | 000 |