The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedical Total Knee Stem Extender.
Device ID | K924482 |
510k Number | K924482 |
Device Name: | HOWMEDICAL TOTAL KNEE STEM EXTENDER |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-03 |
Decision Date | 1994-02-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327044843 | K924482 | 000 |
07613327044713 | K924482 | 000 |
07613327044706 | K924482 | 000 |
07613327044690 | K924482 | 000 |
07613327044683 | K924482 | 000 |
07613327044676 | K924482 | 000 |
07613327044669 | K924482 | 000 |
07613327044652 | K924482 | 000 |
07613327044645 | K924482 | 000 |
07613327044638 | K924482 | 000 |
07613327044621 | K924482 | 000 |
07613327044720 | K924482 | 000 |
07613327044737 | K924482 | 000 |
07613327044836 | K924482 | 000 |
07613327044829 | K924482 | 000 |
07613327044812 | K924482 | 000 |
07613327044805 | K924482 | 000 |
07613327044799 | K924482 | 000 |
07613327044782 | K924482 | 000 |
07613327044775 | K924482 | 000 |
07613327044768 | K924482 | 000 |
07613327044751 | K924482 | 000 |
07613327044744 | K924482 | 000 |
07613327044614 | K924482 | 000 |