| Primary Device ID | M695409652560 |
| NIH Device Record Key | 85812be5-9fa3-4345-b19f-253ecc69384c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Headed Screw System |
| Version Model Number | 409-65256 |
| Catalog Number | 409-65256 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical LLC |
| 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 | true |
| 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 | M695409652560 [Primary] |
| HIBCC | M695409652561B [Previous] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
[M695409652560]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| 00810030824169 | 2.5 HD CANN SHT SCR X50 |
| 00810030824152 | 2.5 HD CANN SHT SCR X45 |
| 00810030824145 | 2.5 HD CANN SHT SCR X40 |
| 00810030824138 | 2.5 HD CANN SHT SCR X38 |
| 00810030824121 | 2.5 HD CANN SHT SCR X36 |
| 00810030824114 | 2.5 HD CANN SHT SCR X34 |
| 00810030824107 | 2.5 HD CANN SHT SCR X32 |
| 00810030824091 | 2.5 HD CANN SHT SCR X30 |
| 00810030824084 | 2.5 HD CANN SHT SCR X28 |
| 00810030824077 | 2.5 HD CANN SHT SCR X26 |
| 00810030824060 | 2.5 HD CANN SHT SCR X24 |
| 00810030824053 | 2.5 HD CANN SHT SCR X22 |
| 00810030824046 | 2.5 HD CANN SHT SCR X20 |
| 00810030824039 | 2.5 HD CANN SHT SCR X18 |
| 00810030824022 | 2.5 HD CANN SHT SCR X16 |
| 00810030824015 | 2.5 HD CANN SHT SCR X14 |
| 00810030824008 | 2.5 HD CANN SHT SCR X12 |
| 00810030823995 | 2.5 HD CANN SHT SCR X10 |
| 00810030823728 | 2.0 HD CANN SHT SCR X40 |
| 00810030823711 | 2.0 HD CANN SHT SCR X35 |
| 00810030823704 | 2.0 HD CANN SHT SCR X30 |
| 00810030823698 | 2.0 HD CANN SHT SCR X28 |
| 00810030823681 | 2.0 HD CANN SHT SCR X26 |
| 00810030823674 | 2.0 HD CANN SHT SCR X24 |
| 00810030823667 | 2.0 HD CANN SHT SCR X22 |
| 00810030823650 | 2.0 HD CANN SHT SCR X20 |
| 00810030823643 | 2.0 HD CANN SHT SCR X18 |
| 00810030823636 | 2.0 HD CANN SHT SCR X16 |
| 00810030823629 | 2.0 HD CANN SHT SCR X14 |
| 00810030823612 | 2.0 HD CANN SHT SCR X12 |
| 00810030823605 | 2.0 HD CANN SHT SCR X10 |
| 00810030823353 | 1.5 HD SOLID SHT SCR X30 |
| 00810030823346 | 1.5 HD SOLID SHT SCR X28 |
| 00810030823339 | 1.5 HD SOLID SHT SCR X26 |
| 00810030823322 | 1.5 HD SOLID SHT SCR X24 |
| 00810030823315 | 1.5 HD SOLID SHT SCR X22 |
| 00810030823308 | 1.5 HD SOLID SHT SCR X20 |
| 00810030823292 | 1.5 HD SOLID SHT SCR X18 |
| 00810030823285 | 1.5 HD SOLID SHT SCR X16 |
| 00810030823278 | 1.5 HD SOLID SHT SCR X14 |
| 00810030823261 | 1.5 HD SOLID SHT SCR X12 |
| 00810030823254 | 1.5 HD SOLID SHT SCR X10 |
| 00810030823247 | 1.5 HD SOLID SHT SCR X08 |
| M695409653400 | Headed Cannulated Screw Long Ø6.5mm x 40mm |
| M695409653950 | Headed Cannulated Screw Long Ø6.5mm x 95mm |
| M695409653900 | Headed Cannulated Screw Long Ø6.5mm x 90mm |
| M695409653850 | Headed Cannulated Screw Long Ø6.5mm x 85mm |
| M695409653480 | Headed Cannulated Screw Long Ø6.5mm x 48mm |
| M695409653460 | Headed Cannulated Screw Long Ø6.5mm x 46mm |
| M695409653450 | Headed Cannulated Screw Long Ø6.5mm x 45mm |