FDA.reportPublic FDA data

Centerpiece Plate Fixation System

Primary DI
00763000552237
Brand
Centerpiece Plate Fixation System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
8532465
Device description
RESCUE SCREW 8532465 ODLP 2.4 X 5MM
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
00763000552237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000552237007630005522377630005522370763000552237

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-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
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
00199150081905Medtronic Reusable InstrumentsX04260022026-07-30
00199150083107Medtronic Reusable InstrumentsEX10040072026-07-30
00199150083879Medtronic Reusable InstrumentsX09074112026-07-30
00763000887216MSB CD HORIZON Spinal System65435352026-07-30
00721902975158GDLH® Posterior Spinal SystemX0196-1112015-08-05
00721902975189GDLH® Posterior Spinal SystemX0196-1222015-08-05
00721902975219GDLH® Posterior Spinal SystemX0196-1262015-08-05
00721902975226GDLH® Posterior Spinal SystemX0196-1282015-08-05
00721902975233GDLH® Posterior Spinal SystemX0196-1302015-08-05
00673978130316GDLH® Posterior Spinal SystemX0196-1042015-08-24
00673978130347GDLH® Posterior Spinal SystemX0196-1072015-08-24
00673978130361GDLH® Posterior Spinal SystemX0196-1092015-08-24
00673978130385GDLH® Posterior Spinal SystemX0196-1122015-08-23
00673978130392GDLH® Posterior Spinal SystemX0196-1142015-08-24
00673978130408GDLH® Posterior Spinal SystemX0196-1162015-08-24
00673978130415GDLH® Posterior Spinal SystemX0196-1182015-08-24
00673978130422GDLH® Posterior Spinal SystemX0196-1202015-08-24
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35262026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemG365PT35282026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03662663146555Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
03662663146562Gallery Laminoplasty Fixation SystemHighridge Medical, LLCNQW2026-01-13
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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
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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
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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
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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