The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Pca Modular Knee Constrained Tibial Insert.
| Device ID | K894403 |
| 510k Number | K894403 |
| Device Name: | PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-17 |
| Decision Date | 1990-02-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540322722 | K894403 | 000 |
| 04546540322845 | K894403 | 000 |
| 04546540322852 | K894403 | 000 |
| 04546540322876 | K894403 | 000 |
| 04546540322883 | K894403 | 000 |
| 04546540322890 | K894403 | 000 |
| 04546540322906 | K894403 | 000 |
| 04546540322913 | K894403 | 000 |
| 04546540322920 | K894403 | 000 |
| 04546540322838 | K894403 | 000 |
| 04546540322821 | K894403 | 000 |
| 04546540322814 | K894403 | 000 |
| 04546540322739 | K894403 | 000 |
| 04546540322746 | K894403 | 000 |
| 04546540322753 | K894403 | 000 |
| 04546540322760 | K894403 | 000 |
| 04546540322777 | K894403 | 000 |
| 04546540322784 | K894403 | 000 |
| 04546540322791 | K894403 | 000 |
| 04546540322807 | K894403 | 000 |
| 04546540322937 | K894403 | 000 |
| 04546540322944 | K894403 | 000 |
| 04546540323071 | K894403 | 000 |
| 04546540323088 | K894403 | 000 |
| 04546540323095 | K894403 | 000 |
| 04546540323101 | K894403 | 000 |
| 04546540323118 | K894403 | 000 |
| 04546540323125 | K894403 | 000 |
| 04546540323132 | K894403 | 000 |
| 04546540323149 | K894403 | 000 |
| 04546540323064 | K894403 | 000 |
| 04546540323057 | K894403 | 000 |
| 04546540323040 | K894403 | 000 |
| 04546540322951 | K894403 | 000 |
| 04546540322968 | K894403 | 000 |
| 04546540322975 | K894403 | 000 |
| 04546540322982 | K894403 | 000 |
| 04546540322999 | K894403 | 000 |
| 04546540323002 | K894403 | 000 |
| 04546540323026 | K894403 | 000 |
| 04546540323033 | K894403 | 000 |
| 04546540323156 | K894403 | 000 |