Primary Device ID | 00840967123486 |
NIH Device Record Key | 0be0e859-91ca-4762-8624-100914a79933 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pegasus Anchored Cervical Interbody System |
Version Model Number | 22930 |
Company DUNS | 602465783 |
Company Name | ALPHATEC SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
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 | 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 |
---|---|
GS1 | 00840967123486 [Primary] |
OVE | Intervertebral fusion device with integrated fixation, cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840967123486]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-14 |
00840967154527 - Sigma | 2025-07-31 ANNULOTOMY KNIFE |
00190376661100 - Invictus | 2025-07-30 1/4 Sq. with Additional Flats Adapter |
00190376661117 - Invictus | 2025-07-30 Tri-Flat Adapter |
00190376661124 - Invictus | 2025-07-30 Small Hudson Adapter |
00190376661131 - Invictus | 2025-07-30 Large Hudson Adapter |
00190376135373 - Invictus | 2025-07-28 POLYAXIAL SCREW 7.0mm X 35mm |
00190376135380 - Invictus | 2025-07-28 POLYAXIAL SCREW 7.0mm X 40mm |
00190376135397 - Invictus | 2025-07-28 POLYAXIAL SCREW 7.0mm X 45mm |