Primary Device ID | 07630030827006 |
NIH Device Record Key | 516c6aae-8579-499b-a7f3-d94a4ffc31d1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GMK Sphere Total Knee System |
Version Model Number | 02.12.0614CR |
Company DUNS | 488227125 |
Company Name | Medacta International SA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07630030827006 [Primary] |
JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2014-11-18 |
07630040707848 | GMK Sphere CR Tibial Insert #6R 14mm |
07630040707831 | GMK Sphere CR Tibial Insert #6L 14mm |
07630040707824 | GMK Sphere CR Tibial Insert #6R 13mm |
07630040707817 | GMK Sphere CR Tibial Insert #6L 13mm |
07630040707800 | GMK Sphere CR Tibial Insert #6R 12mm |
07630040707794 | GMK Sphere CR Tibial Insert #6L 12mm |
07630040707787 | GMK Sphere CR Tibial Insert #6R 11mm |
07630040707770 | GMK Sphere CR Tibial Insert #6L 11mm |
07630040707763 | GMK Sphere CR Tibial Insert #6R 10mm |
07630040707756 | GMK Sphere CR Tibial Insert #6L 10mm |
07630040707701 | GMK Sphere CR Tibial Insert #5R 14mm |
07630040707695 | GMK Sphere CR Tibial Insert #5L 14mm |
07630040707688 | GMK Sphere CR Tibial Insert #5R 13mm |
07630040707671 | GMK Sphere CR Tibial Insert #5L 13mm |
07630040707664 | GMK Sphere CR Tibial Insert #5R 12mm |
07630040707657 | GMK Sphere CR Tibial Insert #5L 12mm |
07630040707640 | GMK Sphere CR Tibial Insert #5R 11mm |
07630040707633 | GMK Sphere CR Tibial Insert #5L 11mm |
07630040707626 | GMK Sphere CR Tibial Insert #5R 10mm |
07630040707619 | GMK Sphere CR Tibial Insert #5L 10mm |
07630040707565 | GMK Sphere CR Tibial Insert #4R 14mm |
07630040707558 | GMK Sphere CR Tibial Insert #4L 14mm |
07630040707541 | GMK Sphere CR Tibial Insert #4R 13mm |
07630040707534 | GMK Sphere CR Tibial Insert #4L 13mm |
07630040707527 | GMK Sphere CR Tibial Insert #4R 12mm |
07630040707510 | GMK Sphere CR Tibial Insert #4L 12mm |
07630040707503 | GMK Sphere CR Tibial Insert #4R 11mm |
07630040707497 | GMK Sphere CR Tibial Insert #4L 11mm |
07630040707480 | GMK Sphere CR Tibial Insert #4R 10mm |
07630040707473 | GMK Sphere CR Tibial Insert #4L 10mm |
07630040707428 | GMK Sphere CR Tibial Insert #3R 14mm |
07630040707411 | GMK Sphere CR Tibial Insert #3L 14mm |
07630040707404 | GMK Sphere CR Tibial Insert #3R 13mm |
07630040707398 | GMK Sphere CR Tibial Insert #3L 13mm |
07630040707381 | GMK Sphere CR Tibial Insert #3R 12mm |
07630040707374 | GMK Sphere CR Tibial Insert #3L 12mm |
07630040707367 | GMK Sphere CR Tibial Insert #3R 11mm |
07630040707350 | GMK Sphere CR Tibial Insert #3L 11mm |
07630040707343 | GMK Sphere CR Tibial Insert #3R 10mm |
07630040707336 | GMK Sphere CR Tibial Insert #3L 10mm |
07630040707282 | GMK Sphere CR Tibial Insert #2R 14mm |
07630040707275 | GMK Sphere CR Tibial Insert #2L 14mm |
07630040707268 | GMK Sphere CR Tibial Insert #2R 13mm |
07630040707251 | GMK Sphere CR Tibial Insert #2L 13mm |
07630040707244 | GMK Sphere CR Tibial Insert #2R 12mm |
07630040707237 | GMK Sphere CR Tibial Insert #2L 12mm |
07630040707220 | GMK Sphere CR Tibial Insert #2R 11mm |
07630040707213 | GMK Sphere CR Tibial Insert #2L 11mm |
07630040707206 | GMK Sphere CR Tibial Insert #2R 10mm |
07630040707190 | GMK Sphere CR Tibial Insert #2L 10mm |