GDLH® Posterior Spinal System
GUDID 00673978130385
ROD 5.5X12CM HEX TI
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00673978130385 |
| NIH Device Record Key | 9fec78d6-6996-4357-87da-467b1effbfb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GDLH® Posterior Spinal System |
| Version Model Number | X0196-112 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | true |
| 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 |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 12 Centimeter |
| Outer Diameter | 5.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978130385 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K000991
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
[00673978130385]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-23 |
On-Brand Devices [GDLH® Posterior Spinal System]
| 00673978130422 | ROD 5.5X20CM HEX TI |
| 00673978130415 | ROD 5.5X18CM HEX SS |
| 00673978130408 | ROD 5.5X16CM HEX SS |
| 00673978130392 | ROD 5.5X14CM HEX TI |
| 00673978130385 | ROD 5.5X12CM HEX TI |
| 00673978130361 | ROD 5.5X9CM HEX TI |
| 00673978130347 | ROD 5.5X7CM HEX TI |
| 00673978130316 | ROD 5.5X4CM HEX TI |
| 00673978130163 | TSR TT T-BOLT 14MM 5.5 TI |
| 00673978061825 | ROD 855-011 5.5 MM HEX-END ROD L20 TI |
| 00673978056258 | ROD 845-011 5.5MM HEX END L20 51CM |
| 00721902975233 | ROD 5.5X30CM-TI-HEX |
| 00721902975226 | ROD 5.5X28CM-TI-HEX |
| 00721902975219 | ROD 5.5X26CM-TI-HEX |
| 00721902975189 | ROD 5.5X22CM-TI-HEX |
| 00721902975158 | ROD 5.5X11CM-TI-HEX |
Trademark Results [GDLH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GDLH 74476637 1998558 Dead/Cancelled |
SDGI HOLDINGS, INC. 1994-01-05 |
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