OPSInsight™ 1200-0000
GUDID 09351327000848
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
OPTIMIZED ORTHO PTY LTD
Orthopaedic/craniofacial implantation planning software| Primary Device ID | 09351327000848 |
| NIH Device Record Key | 23766a43-c426-4b4a-9646-d4dd77ae8c11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPSInsight™ |
| Version Model Number | 1.2 |
| Catalog Number | 1200-0000 |
| Company DUNS | 745735175 |
| Company Name | OPTIMIZED ORTHO PTY LTD |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com | |
| Phone | 1 (772) 321-2478 |
| Lucinda.Gerber@Coringroup.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09351327000848 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202805
FDA Product Code
| LLZ | System, Image Processing, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-24 |
| Device Publish Date | 2021-03-16 |
Devices Manufactured by OPTIMIZED ORTHO PTY LTD
| 09351327001302 - Optimized Ortho Positioning (OPS) System | 2022-06-03 OPS Reusable Instrument Inner Tray |
| 09351327001364 - Optimized Ortho Positioning (OPS) System | 2022-06-03 OPS Reusable Instrument Outer Tray with Lid |
| 09351327000848 - OPSInsight™ | 2021-03-24OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty. |
| 09351327000848 - OPSInsight™ | 2021-03-24 OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, |
| 09351327000695 - OPS | 2020-02-25 Impactor Canister Adaptor 42.5mm |
| 09351327000701 - OPS | 2020-02-25 Right Angle Clamp |
| 09351327000718 - OPS | 2020-02-25 Reference Arm Short |
| 09351327000725 - OPS | 2020-02-25 Reference Arm Long |
| 09351327000732 - OPS | 2020-02-25 Short Curved Guide Handle |
Trademark Results [OPSInsight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPSINSIGHT 87004801 not registered Live/Pending |
Rosemount Aerospace Inc. 2016-04-18 |
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