Insignia 7000-6604
GUDID 07613327511536
Hip Stem - High Offset
Howmedica Osteonics Corp.
Coated hip femur prosthesis, modular| Primary Device ID | 07613327511536 |
| NIH Device Record Key | a049601a-f4c8-409c-b5c9-7ea5b2f2be9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Insignia |
| Version Model Number | 7000-6604 |
| Catalog Number | 7000-6604 |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327511536 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211703
FDA Product Code
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-09 |
| Device Publish Date | 2021-12-01 |
On-Brand Devices [Insignia]
| 07613327511628 | Hip Stem - High Offset |
| 07613327511611 | Hip Stem - Standard Offset |
| 07613327511604 | Hip Stem - Standard Offset |
| 07613327511598 | Hip Stem - High Offset |
| 07613327511581 | Hip Stem - Standard Offset |
| 07613327511574 | Hip Stem - Standard Offset |
| 07613327511567 | Hip Stem - Standard Offset |
| 07613327511550 | Hip Stem - Standard Offset |
| 07613327511543 | Hip Stem - High Offset |
| 07613327511536 | Hip Stem - High Offset |
| 07613327511529 | Hip Stem - Standard Offset |
| 07613327511512 | Hip Stem - High Offset |
| 07613327511505 | Hip Stem - High Offset |
| 07613327511499 | Hip Stem - High Offset |
| 07613327511482 | Hip Stem - High Offset |
| 07613327511475 | Hip Stem - High Offset |
| 07613327511468 | Hip Stem - High Offset |
| 07613327511451 | Hip Stem - High Offset |
| 07613327511444 | Hip Stem - Standard Offset |
| 07613327511437 | Hip Stem - Standard Offset |
| 07613327511420 | Hip Stem - Standard Offset |
| 07613327511413 | Hip Stem - Standard Offset |
| 07613327511406 | Hip Stem - High Offset |
| 07613327511390 | Hip Stem - Standard Offset |
Trademark Results [Insignia]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSIGNIA 98152847 not registered Live/Pending |
Stylish Associates LLC 2023-08-28 |
 INSIGNIA 98152845 not registered Live/Pending |
Stylish Associates LLC 2023-08-28 |
 INSIGNIA 98063462 not registered Live/Pending |
GARCIA HUGO C 2023-06-28 |
INSIGNIA 98063462 not registered Live/Pending |
GARCIA, ROBERTO C 2023-06-28 |
 INSIGNIA 97847346 not registered Live/Pending |
Jayco, Inc. 2023-03-20 |
 INSIGNIA 97813239 not registered Live/Pending |
Cardenas-Cuevas, Alejandro 2023-02-27 |
 INSIGNIA 97749310 not registered Live/Pending |
Garcia, Hugo C 2023-01-10 |
 INSIGNIA 97269684 not registered Live/Pending |
JACKSON NEW YORK LLC 2022-02-16 |
 INSIGNIA 90590493 not registered Live/Pending |
Jackson Stack 2021-03-19 |
 INSIGNIA 90568019 not registered Live/Pending |
LMK TECHNOLOGIES, LLC 2021-03-09 |
 INSIGNIA 90207288 not registered Live/Pending |
BBY Solutions, Inc. 2020-09-24 |
 INSIGNIA 90149626 not registered Live/Pending |
SpeeDx Pty Ltd 2020-08-31 |
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