FDA.reportPublic FDA data

MAST QUADRANT™ Retractor System

Primary DI
00885074055169
Brand
MAST QUADRANT™ Retractor System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
9568226
Device description
CAPITAL 9568226 LEFT HALF TUBE 60MM
Published
2016-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043602000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043602000QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek2005-02-23GAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885074055169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885074055169008850740551698850740551690885074055169

GMDN Terms#

Term, Definition table
TermDefinition
Spinal endoscopic-access systemAn assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169524699Reusable Instruments21511302026-09-20
00763000891428CD HORIZON Spinal System559006001602026-09-20
00763000891480CD HORIZON Spinal System559006185502026-09-20
00763000992538INFINITY OCT SystemG36535122026-09-20
00763000992545INFINITY OCT SystemG36535142026-09-20
00763000992569INFINITY OCT SystemG36535182026-09-20
00824846008477Medtronic Reusable InstrumentsEX29420202026-09-19
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841536148640ThompsonThompson Surgical Instruments, Inc.GAD2026-09-20
00192629005419ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005426ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005488ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005495ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005501ADVANCEMicroport Orthopedics Inc.MBH2026-09-18
00192629005518ADVANCEMicroport Orthopedics Inc.MBH2026-09-18
08800322775561Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775578Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
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00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
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