Primary Device ID | 00822409038107 |
NIH Device Record Key | fe3eb1f8-3dbd-43f0-b3d9-41c6d6f705ef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Balanced Knee Revision System |
Version Model Number | 563-2114 |
Company DUNS | 876542390 |
Company Name | Ortho Development Corporation |
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 |
Phone | +1(801)553-9991 |
customerservice@odev.com | |
Phone | +1(801)553-9991 |
customerservice@odev.com |
Height | 14 Millimeter |
Height | 14 Millimeter |
Height | 14 Millimeter |
Height | 14 Millimeter |
Height | 14 Millimeter |
Height | 14 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00822409038107 [Primary] |
JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-12-07 |
Device Publish Date | 2018-11-06 |
00822409040728 | Slotted Stem Ext Diameter 24mm x 150mm |
00822409040711 | Slotted Stem Ext Diameter 24mm x 110mm |
00822409040704 | Slotted Stem Ext Diameter 24mm x 80mm |
00822409040698 | Slotted Stem Ext Diameter 22mm x 150mm |
00822409040681 | Slotted Stem Ext Diameter 22mm x 110mm |
00822409040674 | Slotted Stem Ext Diameter 22mm x 80mm |
00822409040667 | Slotted Stem Ext Diameter 20mm x 150mm |
00822409040650 | Slotted Stem Ext Diameter 20mm x 110mm |
00822409040643 | Slotted Stem Ext Diameter 20mm x 80mm |
00822409040636 | Slotted Stem Ext Diameter 19mm x 150mm |
00822409040629 | Slotted Stem Ext Diameter 19mm x 110mm |
00822409040612 | Slotted Stem Ext Diameter 19mm x 80mm |
00822409040605 | Slotted Stem Ext Diameter 18mm x 150mm |
00822409040599 | Slotted Stem Ext Diameter 18mm x 110mm |
00822409040582 | Slotted Stem Ext Diameter 18mm x 80mm |
00822409040575 | Slotted Stem Ext Diameter 17mm x 150mm |
00822409040568 | Slotted Stem Ext Diameter 17mm x 110mm |
00822409040551 | Slotted Stem Ext Diameter 17mm x 80mm |
00822409040544 | Slotted Stem Ext Diameter 16mm x 150mm |
00822409040537 | Slotted Stem Ext Diameter 16mm x 110mm |
00822409040520 | Slotted Stem Ext Diameter 16mm x 80mm |
00822409040513 | Slotted Stem Ext Diameter 15mm x 150mm |
00822409040506 | Slotted Stem Ext Diameter 15mm x 110mm |
00822409040490 | Slotted Stem Ext Diameter 15mm x 80mm |
00822409040483 | Slotted Stem Ext Diameter 14mm x 150mm |
00822409040476 | Slotted Stem Ext Diameter 14mm x 110mm |
00822409040469 | Slotted Stem Ext Diameter 14mm x 80mm |
00822409040452 | Fluted Stem Ext Diameter 13mm x 150mm |
00822409040445 | Fluted Stem Ext Diameter 13mm x 110mm |
00822409040438 | Fluted Stem Ext Diameter 13mm x 80mm |
00822409040421 | Fluted Stem Ext Diameter 12mm x 150mm |
00822409040414 | Fluted Stem Ext Diameter 12mm x 110mm |
00822409040407 | Fluted Stem Ext Diameter 12mm x 80mm |
00822409040391 | Fluted Stem Ext Diameter 11mm x 150mm |
00822409040384 | Fluted Stem Ext Diameter 11mm x 110mm |
00822409040377 | Fluted Stem Ext Diameter 11mm x 80mm |
00822409040360 | Fluted Stem Ext Diameter 10mm x 150mm |
00822409040353 | Fluted Stem Ext Diameter 10mm x 110mm |
00822409040346 | Fluted Stem Ext Diameter 10mm x 80mm |
00822409040339 | Offset Tibial Tray Sz 7 |
00822409040322 | Offset Tibial Tray Sz 6 |
00822409040315 | Offset Tibial Tray Sz 5 |
00822409040308 | Offset Tibial Tray Sz 4 |
00822409040292 | Offset Tibial Tray Sz 3 |
00822409040285 | Offset Tibial Tray Sz 2 |
00822409040278 | Offset Tibial Tray Sz 1 |
00822409040261 | Sloped Tibial Tray Size 7 |
00822409040254 | Sloped Tibial Tray Size 6 |
00822409040247 | Sloped Tibial Tray Size 5 |
00822409040230 | Sloped Tibial Tray Size 4 |