| Primary Device ID | 00840199515776 | 
| NIH Device Record Key | 5c70ede9-8840-4136-9eb9-cddab67696d1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Replacement Screw | 
| Version Model Number | 7331-41 | 
| Catalog Number | 7331-41 | 
| Company DUNS | 007928633 | 
| Company Name | KOROS U.S.A., INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | true | 
| Serial Number | true | 
| 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 | 
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 | 
| customerservice@korosUSA.com | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840199515776 [Direct Marking] | 
| GS1 | 10840199515773 [Primary] | 
| FZX | Guide, Surgical, Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
[00840199515776]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-01-08 | 
| Device Publish Date | 2024-12-31 | 
| 00840199515783 | Anterior Lumbar Distraction Replacement for Screw 4.5mm | 
| 00840199515776 | Anterior Lumbar Distraction Replacement for Screw 3.5mm |