FDA.reportPublic FDA data

Centerpiece Plate Fixation System

Primary DI
00763000553494
Brand
Centerpiece Plate Fixation System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
G8532463
Device description
RESCUE SCREW G8532463 ODLP 2.4 X 3MM
Published
2022-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQWORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQWOrthosis, Spine, Plate, Laminoplasty, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212428000Centerpiece Plate Fixation SystemMedtronic Sofamor Danek2021-12-13NQW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000553494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000553494007630005534947630005534940763000553494

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

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
00643169190382CLYDESDALE PTC™ Spinal System49268552016-04-17
00643169190399CLYDESDALE PTC™ Spinal System49268502016-04-17
00643169190405CLYDESDALE PTC™ Spinal System49268452016-04-18
00643169190412CLYDESDALE PTC™ Spinal System49268402016-04-17
00643169190429CLYDESDALE PTC™ Spinal System49266602016-04-17
00643169190436CLYDESDALE PTC™ Spinal System49266552016-04-17
00643169190443CLYDESDALE PTC™ Spinal System49266502016-04-17
00643169190450CLYDESDALE PTC™ Spinal System49266452016-04-18
00643169190467CLYDESDALE PTC™ Spinal System49266402016-04-18
00643169190481CLYDESDALE PTC™ Spinal System49264552016-04-18
00643169190504CLYDESDALE PTC™ Spinal System49868602016-04-17
00643169190559CLYDESDALE PTC™ Spinal System49866602016-04-17
00643169190566CLYDESDALE PTC™ Spinal System49866552016-04-17
00643169190573CLYDESDALE PTC™ Spinal System49866502016-04-17
00643169190580CLYDESDALE PTC™ Spinal System49866452016-04-17
00643169190597CLYDESDALE PTC™ Spinal System49866402016-04-17
00643169190603CLYDESDALE PTC™ Spinal System49864602016-04-17
00643169190610CLYDESDALE PTC™ Spinal System49864552016-04-18
00643169190634CLYDESDALE PTC™ Spinal System49864452016-04-17
00643169190658CLYDESDALE PTC™ Spinal System49862602016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663146524Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146531Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146548Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146555Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146562Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146579Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146586Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146593Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146609Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146616Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146623Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146234Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146241Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146258Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146265Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146272Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146289Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146296Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146302Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146319Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146326Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146333Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146340Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146357Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146364Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146371Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146388Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146395Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146401Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15
03662663146418Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2025-11-15