The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Modular Femoral Head With Offset Trunion.
Device ID | K914675 |
510k Number | K914675 |
Device Name: | MODULAR FEMORAL HEAD WITH OFFSET TRUNION |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
Contact | Sam Son |
Correspondent | Sam Son KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium, MD 21093 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-18 |
Decision Date | 1992-08-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304256224 | K914675 | 000 |
00880304256217 | K914675 | 000 |
00880304256200 | K914675 | 000 |
00880304256194 | K914675 | 000 |
00880304256187 | K914675 | 000 |
00880304255418 | K914675 | 000 |
00880304255395 | K914675 | 000 |
00880304255388 | K914675 | 000 |
00880304007550 | K914675 | 000 |