Primary Device ID | B114213000 |
NIH Device Record Key | c2bb0e81-5f79-4aa6-bb99-f8bedf79003b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cervical Spacer Inserter |
Version Model Number | Cervical Spacer Inserter |
Catalog Number | 213-00 |
Company DUNS | 832116532 |
Company Name | CALVARY SPINE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Phone | 786-301-8006 |
james.r.edw@gmail.com | |
Phone | 786-301-8006 |
james.r.edw@gmail.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B114213000 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B114213000]
Moist Heat or Steam Sterilization
[B114213000]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-04-23 |
Device Publish Date | 2016-03-01 |
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B114155250 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm Diameter 25 mm length |
B114155300 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm diameter 30mm length |
B114155350 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm Diameter 35mm length |
B114155400 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm 40 mm Length |
B114155450 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm Diameter 45mm length |
B114155500 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm Diameter 50mm length |
B114155550 - Calvary Spine Pedicle Screw System | 2020-12-02 Polyaxial Screw 5.5mm Diameter 55mm length |