FDA.reportPublic FDA data

CAPSTONE PTC™ Spinal System

Primary DI
00643169187443
Brand
CAPSTONE PTC™ Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
3992608
Device description
SPACER 3992608 26MM X 8MM
Published
2016-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133205000
K172199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133205000CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEMMedtronic Sofamor Danek USA, Inc.2014-03-13MAX
K172199000ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek2017-09-19MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169187443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169187443006431691874436431691874430643169187443

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19
00643169511729MSB SOVEREIGN™ Spinal System90100020322026-07-19
00643169511736MSB SOVEREIGN™ Spinal System90100020332026-07-19
00643169511774MSB SOVEREIGN™ Spinal System90100020342026-07-19
00643169511781MSB SOVEREIGN™ Spinal System90100020352026-07-19
00643169511798MSB SOVEREIGN™ Spinal System90100020362026-07-19
00643169511804MSB SOVEREIGN™ Spinal System90100020372026-07-19
00643169511811MSB SOVEREIGN™ Spinal System90100020382026-07-19
00643169511828MSB SOVEREIGN™ Spinal System90100020392026-07-19
00643169511873MSB SOVEREIGN™ Spinal System90100020052026-07-19
00643169511880MSB SOVEREIGN™ Spinal System90100020062026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000704537MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000880897MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881153MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881382MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881399MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
00763000881405MSB CAPSTONE Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-07-19
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