The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Modified New Jersey Femoral Hip Resurfacing Compon.
| Device ID | K904870 |
| 510k Number | K904870 |
| Device Name: | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| Applicant | ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Contact | Michael J Pappas |
| Correspondent | Michael J Pappas ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Product Code | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-23 |
| Decision Date | 1991-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193023100 | K904870 | 000 |
| 00814193025753 | K904870 | 000 |
| 00814193025746 | K904870 | 000 |
| 00814193025739 | K904870 | 000 |
| 00814193025722 | K904870 | 000 |
| 00814193025715 | K904870 | 000 |
| 00814193025708 | K904870 | 000 |
| 00814193025692 | K904870 | 000 |
| 00814193025685 | K904870 | 000 |
| 00814193025678 | K904870 | 000 |
| 00814193025661 | K904870 | 000 |
| 00814193022981 | K904870 | 000 |
| 00814193022998 | K904870 | 000 |
| 00814193023094 | K904870 | 000 |
| 00814193023087 | K904870 | 000 |
| 00814193023070 | K904870 | 000 |
| 00814193023063 | K904870 | 000 |
| 00814193023056 | K904870 | 000 |
| 00814193023049 | K904870 | 000 |
| 00814193023032 | K904870 | 000 |
| 00814193023025 | K904870 | 000 |
| 00814193023018 | K904870 | 000 |
| 00814193023001 | K904870 | 000 |
| 00814193025654 | K904870 | 000 |