Duns Number:488227125
Device Description: Full Spine Model Scaled 1:2 MediumFull Spine Model Medium
Catalog Number
-
Brand Name
Spine Instruments
Version/Model Number
7.0034
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173472
Product Code
PQC
Product Code Name
Pedicle Screw Placement Guide
Public Device Record Key
220dbcf6-b608-4425-94eb-36f3c89ebe54
Public Version Date
April 14, 2021
Public Version Number
1
DI Record Publish Date
April 06, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8200 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9084 |