The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duracon Baseplates.
| Device ID | K936008 |
| 510k Number | K936008 |
| Device Name: | DURACON BASEPLATES |
| 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 | 1993-12-16 |
| Decision Date | 1995-08-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540307194 | K936008 | 000 |
| 04546540307002 | K936008 | 000 |
| 04546540306999 | K936008 | 000 |
| 04546540306982 | K936008 | 000 |
| 04546540306975 | K936008 | 000 |
| 04546540306968 | K936008 | 000 |
| 04546540306951 | K936008 | 000 |
| 04546540306944 | K936008 | 000 |
| 04546540306937 | K936008 | 000 |
| 04546540306920 | K936008 | 000 |
| 04546540306913 | K936008 | 000 |
| 04546540306906 | K936008 | 000 |
| 04546540306890 | K936008 | 000 |
| 04546540306883 | K936008 | 000 |
| 04546540306876 | K936008 | 000 |
| 04546540306869 | K936008 | 000 |
| 04546540306852 | K936008 | 000 |
| 04546540307019 | K936008 | 000 |
| 04546540307026 | K936008 | 000 |
| 04546540307187 | K936008 | 000 |
| 04546540307170 | K936008 | 000 |
| 04546540307163 | K936008 | 000 |
| 04546540307156 | K936008 | 000 |
| 04546540307149 | K936008 | 000 |
| 04546540307132 | K936008 | 000 |
| 04546540307125 | K936008 | 000 |
| 04546540307118 | K936008 | 000 |
| 04546540307101 | K936008 | 000 |
| 04546540307095 | K936008 | 000 |
| 04546540307088 | K936008 | 000 |
| 04546540307071 | K936008 | 000 |
| 04546540307064 | K936008 | 000 |
| 04546540307057 | K936008 | 000 |
| 04546540307040 | K936008 | 000 |
| 04546540307033 | K936008 | 000 |
| 04546540306845 | K936008 | 000 |