FDA.report

REFLECT

Primary DI
00193982313166
Brand
REFLECT
Company
GLOBUS MEDICAL, INC.
Model
1244.0055
Device description
5.5mm Threaded Staple, 3 Prong
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
false
Single use
true

Related Records

Product Codes

CodeName
QHPVertebral body tethering system

Product Code Classifications

CodeDeviceSpecialtyClass
QHPVertebral Body Tethering SystemUnknownN

Premarket Submissions

SubmissionSupplement
H210002000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
H210002000

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00193982313166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982313166001939823131661939823131660193982313166

GMDN Terms

TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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

Other Devices From This Company

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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 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