| Primary Device ID | M9432001570000 |
| NIH Device Record Key | a4b2fae3-7ec9-4c2f-8704-421f48c7412a |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 20-0157-000 |
| 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 | M9432001570000 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
[M9432001570000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-11 |
| Device Publish Date | 2024-07-03 |
| M9432002200000 - Minuteman | 2025-06-23 Wrench |
| M9433500070000 - Patriot SI | 2025-06-23 Single Use Instrument Kit |
| M9432000010020 - Minuteman | 2025-02-10 Guide Wire without Male Thread |
| M9432000130000 - Minuteman | 2025-01-30 Direct Drive T-Handle |
| M9432001010000 - Minuteman | 2025-01-30 Adapter, Hex, Manual Ratchet Driver Assembly |
| M9432001040000 - Minuteman | 2025-01-30 Mini Wing Reset |
| M9432001190000 - Minuteman | 2025-01-30 Wing Reset Instrument |
| M9432001210000 - Minuteman | 2025-01-30 Ratchet Wrench, Manual |