The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Shoulder Stems.
Device ID | K061454 |
510k Number | K061454 |
Device Name: | EXACTECH EQUINOXE SHOULDER STEMS |
Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
Contact | Maritza Elias |
Correspondent | Maritza Elias EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
Product Code | HSD |
CFR Regulation Number | 888.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-25 |
Decision Date | 2006-06-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10885862530479 | K061454 | 000 |
10885862530462 | K061454 | 000 |
10885862580108 | K061454 | 000 |
10885862573704 | K061454 | 000 |
10885862557841 | K061454 | 000 |
10885862080073 | K061454 | 000 |
10885862080066 | K061454 | 000 |