FDA.report

CAPITOL

Primary DI
00889095035568
Brand
CAPITOL
Company
GLOBUS MEDICAL, INC.
Model
111.334
Device description
3.5mm CAPITOL Polyaxial Screw, 34mm
Published
2015-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NKGOrthosis, cervical pedicle screw spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889095035568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095035568008890950355688890950355680889095035568

GMDN Terms

TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes

TypeValueUnit
Length34Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags

DUNS number
139105691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
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00193982534035ANTHEM1181.82042026-01-27
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00193982534059ANTHEM1181.82062026-01-27
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