| Primary Device ID | 00810141040007 |
| NIH Device Record Key | 77c47fe0-a240-47cb-8178-1998a317e9a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Foundation Surgical Instruments |
| Version Model Number | FS50-010000 |
| Catalog Number | FS50-010000 |
| Company DUNS | 119029419 |
| Company Name | FOUNDATION SURGICAL GROUP INC |
| 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 | 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 |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com | |
| Phone | 727-209-7436 |
| Foundationsurgical@orthoex.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810141040007 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
[00810141040007]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-13 |
| Device Publish Date | 2026-03-05 |
| 00810141040946 | Tap Straight |
| 00810141040939 | Inserter Lateral |
| 00810141040922 | Staple Driver |
| 00810141040007 | Staple Rotator |