FDA.reportPublic FDA data

REFLECT

Primary DI
00193982310646
Brand
REFLECT
Company
GLOBUS MEDICAL, INC.
Model
5244.0736S
Device description
REFLECT HA Monoaxial Screw, 7.5x35mm
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QHPVertebral body tethering system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHPVertebral Body Tethering SystemUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H210002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H210002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982310646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982310646001939823106461939823106460193982310646

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01
00889095782486CREO6200.14052019-08-01
00193982647650ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.31272026-02-10
00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
00193982647674ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50212026-02-10
00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663282055The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282062The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282079The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282086The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282093The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282109The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282116The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282123The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282130The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282147The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282154The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282161The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282178The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282185The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282192The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282208The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282215The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282222The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282239The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282246The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282253The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282260The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282277The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282314The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282321The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282338The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282345The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282352The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282369The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16
03662663282376The Tether Vertebral Body Tethering SystemHighridge Medical, LLCQHP2026-02-16