| Primary Device ID | M9432001280040 |
| NIH Device Record Key | 634a5854-a20d-46ae-891e-ffd12e2ec223 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 20-0128-004 |
| Company DUNS | 963359513 |
| Company Name | Spinal Simplicity, LLC |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | M9432001280040 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
[M9432001280040]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-05 |
| Device Publish Date | 2024-07-26 |
| M9432000260000 - Minuteman | 2025-01-16 Minuteman Insertion Instrument |
| M9432000270000 - Minuteman | 2025-01-16 Wrench SZ 8/10 |
| M9432000270010 - Minuteman | 2025-01-16 Speed Wrench SZ 8/10 |
| M9432000280000 - Minuteman | 2025-01-16 Wrench SZ 12/14 |
| M9432000280010 - Minuteman | 2025-01-16 Speed Wrench SZ 12/14 |
| M9432000290000 - Minuteman | 2025-01-16 Wrench SZ 16 |
| M9432000290010 - Minuteman | 2025-01-16 Speed Wrench SZ 16 |
| M9432000490000 - Minuteman | 2025-01-16 Aiming Device Support Handle |