Primary Device ID | B114100070 |
NIH Device Record Key | bfeec117-3e22-4e84-92b9-526ca3859718 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lumbar Interbody Spacer |
Version Model Number | 7mm Crescent |
Catalog Number | 100-07 |
Company DUNS | 832116532 |
Company Name | CALVARY SPINE, 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 | 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 |
Phone | 786-301-8006 |
james.r.edw@gmail.com | |
Phone | 786-301-8006 |
james.r.edw@gmail.com |
Height | 7 Millimeter |
Height | 7 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B114100070 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B114100070]
Moist Heat or Steam Sterilization
[B114100070]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2016-03-01 |
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