PYRAMID® +4 Anterior Lumbar Plate System
GUDID 00613994286055
PLATE 9874039 4HOLE 39MM
MEDTRONIC SOFAMOR DANEK, INC.
Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage| Primary Device ID | 00613994286055 |
| NIH Device Record Key | 9e71ffae-a08d-4c8e-828b-60336b6c3c5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYRAMID® +4 Anterior Lumbar Plate System |
| Version Model Number | 9874039 |
| 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 | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
| Outer Diameter | 39 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994286055 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071416
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
Moist Heat or Steam Sterilization
[00613994286055]
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 | 2015-08-18 |
On-Brand Devices [PYRAMID® +4 Anterior Lumbar Plate System]
| 00613994927897 | SCR X1010598 5.5 RED MAS TI OG 9.5X100 |
| 00613994923004 | PLATE X1210069 PYR FIXED TI 4HOLE 46MM |
| 00613994922991 | PLATE X1210068 PYR FIXED TI 4HOLE 44MM |
| 00613994922984 | PLATE X1210067 PYR FIXED TI 4HOLE 42MM |
| 00613994922977 | PLATE X1210066 PYR FIXED TI 4HOLE 40MM |
| 00613994922960 | PLATE X1210065 PYR FIXED TI 4HOLE 38MM |
| 00613994922953 | PLATE X1210064 PYR FIXED TI 4HOLE 36MM |
| 00613994922946 | PLATE X1210063 PYR FIXED TI 3HOLE 42MM |
| 00613994922939 | PLATE X1210062 PYR FIXED TI 3HOLE 40MM |
| 00613994922922 | PLATE X1210061 PYR FIXED TI 3HOLE 38MM |
| 00613994922915 | PLATE X1210060 PYR FIXED TI 3HOLE 36MM |
| 00613994922908 | PLATE X1210059 PYR FIXED TI 3HOLE 34MM |
| 00613994922892 | SCR X1210089 PYR FIXED TI CANC 7.0X35 |
| 00613994922885 | SCR X1210088 PYR FIXED TI CANC 7.0X32.5 |
| 00613994922878 | SCR X1210087 PYR FIXED TI CANC 7.0X30 |
| 00613994922861 | SCR X1210086 PYR FIXED TI CANC 7.0X27.5 |
| 00613994922854 | SCR X1210085 PYR FIXED TI CANC 7.0X25 |
| 00613994922847 | SCR X1210084 PYR FIXED TI CANC 7.0X22.5 |
| 00613994922830 | SCR X1210083 PYR FIXED TI CANC 7.0X20 |
| 00613994922823 | SCR X1210078 PYR FIXED TI CANC 6.5X35 |
| 00613994922816 | SCR X1210077 PYR FIXED TI CANC 6.5X32.5 |
| 00613994922809 | SCR X1210076 PYR FIXED TI CANC 6.5X30 |
| 00613994922793 | SCR X1210075 PYR FIXED TI CANC 6.5X27.5 |
| 00613994922786 | SCR X1210074 PYR FIXED TI CANC 6.5X25 |
| 00613994922779 | SCR X1210073 PYR FIXED TI CANC 6.5X22.5 |
| 00613994922762 | SCR X1210072 PYR FIXED TI CANC 6.5X20 |
| 00613994681454 | SCREW X0909048 PYR TI CANC DUALLD 6.5X35 |
| 00613994681447 | SCREW X0909047 PYR TI CANC DULD 6.5X32.5 |
| 00613994681430 | SCREW X0909046 PYR TI CANC DUALLD 6.5X30 |
| 00613994681423 | SCREW X0909045 PYR TI CANC DULD 6.5X27.5 |
| 00613994681416 | SCREW X0909044 PYR TI CANC DUALLD 6.5X25 |
| 00613994681409 | SCREW X0909043 PYR TI CANC DULD 6.5X22.5 |
| 00613994681393 | SCREW X0909042 PYR TI CANC DUALLD 6.5X20 |
| 00613994607126 | PLATE X0409001 X0409001 |
| 00613994470294 | PLATE 9873141 3-HOLE 41MM |
| 00613994470287 | PLATE 9873139 3-HOLE 39MM |
| 00613994470270 | PLATE 9873137 3-HOLE 37MM |
| 00613994470263 | PLATE 9873135 3-HOLE 35MM |
| 00613994470256 | PLATE 9873133 3-HOLE 33MM |
| 00613994286826 | PLATE 9874045 4HOLE 45MM |
| 00613994286130 | PLATE 9873033 3HOLE 33MM |
| 00613994286123 | PLATE 9873035 3HOLE 35MM |
| 00613994286116 | PLATE 9873037 3HOLE 37MM |
| 00613994286109 | PLATE 9873039 3HOLE 39MM |
| 00613994286093 | PLATE 9873041 3HOLE 41MM |
| 00613994286079 | PLATE 9874035 4HOLE 35MM |
| 00613994286062 | PLATE 9874037 4HOLE 37MM |
| 00613994286055 | PLATE 9874039 4HOLE 39MM |
| 00613994286048 | PLATE 9874041 4HOLE 41MM |
| 00613994286031 | PLATE 9874043 4HOLE 43MM |
Trademark Results [PYRAMID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PYRAMID 98474181 not registered Live/Pending |
Pyramid LLC 2024-03-29 |
 PYRAMID 98067151 not registered Live/Pending |
Break Even Golf LLC 2023-06-30 |
 PYRAMID 97766475 not registered Live/Pending |
Pyramid Design & Manufacturing 2023-01-24 |
 PYRAMID 97693025 not registered Live/Pending |
Loud Labs, LLC 2022-11-27 |
 PYRAMID 97557401 not registered Live/Pending |
Echeverri Lopez Jose E 2022-08-21 |
 PYRAMID 88932667 not registered Live/Pending |
N15 Co., Ltd. 2020-05-26 |
 PYRAMID 88767087 not registered Live/Pending |
Inteplast Group Corporation 2020-01-21 |
 PYRAMID 88704230 not registered Live/Pending |
The Aloft Organization, LLC 2019-11-23 |
 PYRAMID 88607146 not registered Live/Pending |
Fanimation, Inc. 2019-09-06 |
 PYRAMID 88594349 not registered Live/Pending |
IMPROCROP U.S.A., INC. 2019-08-27 |
 PYRAMID 88575812 not registered Live/Pending |
Web X.0 Media LLC 2019-08-12 |
 PYRAMID 88456723 not registered Live/Pending |
JND Beauty Supplies Inc. 2019-06-03 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.