Primary Device ID | B114201080 |
NIH Device Record Key | aaca0481-e102-46d4-b869-dbb7f9a7463a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cervical Interbody Spacer |
Version Model Number | 8mm Large 14mm x 18mm |
Catalog Number | 201-08 |
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 | 8 Millimeter |
Height | 8 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B114201080 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B114201080]
Moist Heat or Steam Sterilization
[B114201080]
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 |
B114201090 | 9mm Cervical PEEK intervertebral body spacer |
B114201080 | 8mm Cervical PEEK intervertebral body spacer |
B114201070 | 7mm Cervical PEEK intervertebral body spacer |
B114201060 | 6mm Cervical PEEK inter-vertebral body spacer |
B114201050 | 5mm Cervical PEEK inter-vertebral body spacer |
B114200090 | 9mm Cervical PEEK intervertebral body spacer |
B114200080 | 8mm Cervical PEEK intervertebral body spacer |
B114200070 | 7mm Cervical PEEK intervertebral body spacer |
B114200060 | 6mm Cervical PEEK inter-vertebral body spacer |
B114200050 | 5mm Cervical PEEK inter-vertebral body spacer |