FDA.reportPublic FDA data

Foundation Surgical Vertiwedge

Primary DI
00810141047419
Brand
Foundation Surgical Vertiwedge
Company
FOUNDATION SURGICAL GROUP INC
Model
OV426600803
Catalog number
OV426600803
Device description
Vertiwedge 4-Hole, 26W x 60L x 8H x 3L°
Published
2026-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241468000Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.2024-11-07MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810141047419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810141047419008101410474198101410474190810141047419

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
727-209-7436Foundationsurgical@orthoex.com

Regulatory Flags#

DUNS number
119029419
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810141040007Foundation Surgical InstrumentsFS50-010000FS50-0100002026-03-05
00810141040922Foundation Surgical InstrumentsFSN-020000FSN-0200002026-03-05
00810141040939Foundation Surgical InstrumentsFSN-550000FSN-5500002026-03-05
00810141040946Foundation Surgical InstrumentsFSN-160000FSN-1600002026-03-05
00810141048478Foundation Surgical VertiwedgeOV426401415OV4264014152026-02-26
00810141048485Foundation Surgical VertiwedgeOV426451415OV4264514152026-02-26
00810141048492Foundation Surgical VertiwedgeOV426501415OV4265014152026-02-26
00810141048508Foundation Surgical VertiwedgeOV426551415OV4265514152026-02-26
00810141048515Foundation Surgical VertiwedgeOV426601415OV4266014152026-02-26
00810141048577Foundation Surgical VertiwedgeOV426401420OV4264014202026-02-26
00810141048584Foundation Surgical VertiwedgeOV426451420OV4264514202026-02-26
00810141048591Foundation Surgical VertiwedgeOV426501420OV4265014202026-02-26
00810141048607Foundation Surgical VertiwedgeOV426551420OV4265514202026-02-26
00810141048614Foundation Surgical VertiwedgeOV426601420OV4266014202026-02-26
00810141047259Foundation Surgical VertiwedgeOV4HOV4H2026-02-25
00810141047372Foundation Surgical VertiwedgeOV426400803OV4264008032026-02-25
00810141047389Foundation Surgical VertiwedgeOV426450803OV4264508032026-02-25
00810141047396Foundation Surgical VertiwedgeOV426500803OV4265008032026-02-25
00810141047402Foundation Surgical VertiwedgeOV426550803OV4265508032026-02-25
00810141047570Foundation Surgical VertiwedgeOV426401010OV4264010102026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726404267DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407671DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407794DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407824DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407831DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407855DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407862DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407879DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407886DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407893DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407909DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407916DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726408029DSCSINTEA PLUSTEK SRLMQP2015-10-09