The following data is part of a premarket notification filed by Corin Orthopedic Products with the FDA for Cenator Total Hip System.
Device ID | K925866 |
510k Number | K925866 |
Device Name: | CENATOR TOTAL HIP SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | CORIN ORTHOPEDIC PRODUCTS C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan CORIN ORTHOPEDIC PRODUCTS C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-19 |
Decision Date | 1993-09-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055196912311 | K925866 | 000 |
05055196928794 | K925866 | 000 |
05055196928800 | K925866 | 000 |
05055196928817 | K925866 | 000 |
05055196939929 | K925866 | 000 |
05055196939943 | K925866 | 000 |
05055196939967 | K925866 | 000 |
05055196939981 | K925866 | 000 |
05055196957459 | K925866 | 000 |
05055196913400 | K925866 | 000 |
05055196913394 | K925866 | 000 |
05055196912328 | K925866 | 000 |
05055196912335 | K925866 | 000 |
05055196912595 | K925866 | 000 |
05055196912601 | K925866 | 000 |
05055196912618 | K925866 | 000 |
05055196912878 | K925866 | 000 |
05055196912885 | K925866 | 000 |
05055196912892 | K925866 | 000 |
05055196957466 | K925866 | 000 |
05055196957473 | K925866 | 000 |
05055196957480 | K925866 | 000 |
05055196957756 | K925866 | 000 |
05055196957770 | K925866 | 000 |
05055196957947 | K925866 | 000 |
05055196957954 | K925866 | 000 |
05055196957978 | K925866 | 000 |
05055196957985 | K925866 | 000 |
05055196957992 | K925866 | 000 |
05055196968622 | K925866 | 000 |
05055196957749 | K925866 | 000 |
05055196957732 | K925866 | 000 |
05055196957497 | K925866 | 000 |
05055196957534 | K925866 | 000 |
05055196957541 | K925866 | 000 |
05055196957565 | K925866 | 000 |
05055196957572 | K925866 | 000 |
05055196957701 | K925866 | 000 |
05055196957718 | K925866 | 000 |
05055196957725 | K925866 | 000 |
05055196988750 | K925866 | 000 |