The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apollo Knee Tibial Baseplate/knee Tibial Insert.
Device ID | K934381 |
510k Number | K934381 |
Device Name: | APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Joann Ringer |
Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
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 | 1993-09-08 |
Decision Date | 1995-02-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024262133 | K934381 | 000 |
00889024261945 | K934381 | 000 |
00889024261938 | K934381 | 000 |
00889024261921 | K934381 | 000 |
00889024261914 | K934381 | 000 |
00889024261907 | K934381 | 000 |
00889024261891 | K934381 | 000 |
00889024261884 | K934381 | 000 |
00889024261877 | K934381 | 000 |
00889024261860 | K934381 | 000 |
00889024261853 | K934381 | 000 |
00889024261846 | K934381 | 000 |
00889024261839 | K934381 | 000 |
00889024261822 | K934381 | 000 |
00889024261815 | K934381 | 000 |
00889024261808 | K934381 | 000 |
00889024261792 | K934381 | 000 |
00889024261952 | K934381 | 000 |
00889024261969 | K934381 | 000 |
00889024262126 | K934381 | 000 |
00889024262119 | K934381 | 000 |
00889024262102 | K934381 | 000 |
00889024262096 | K934381 | 000 |
00889024262089 | K934381 | 000 |
00889024262072 | K934381 | 000 |
00889024262065 | K934381 | 000 |
00889024262058 | K934381 | 000 |
00889024262041 | K934381 | 000 |
00889024262034 | K934381 | 000 |
00889024262027 | K934381 | 000 |
00889024262010 | K934381 | 000 |
00889024262003 | K934381 | 000 |
00889024261990 | K934381 | 000 |
00889024261983 | K934381 | 000 |
00889024261976 | K934381 | 000 |
00889024261785 | K934381 | 000 |