FDA.reportPublic FDA data

Foundation Surgical Interwedge

Primary DI
00810141046399
Brand
Foundation Surgical Interwedge
Company
FOUNDATION SURGICAL GROUP INC
Model
LB22401420
Catalog number
LB22401420
Device description
Interwedge, 22W x 40L x 14H x 20L°, Sterile (x1)
Published
2026-02-18
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241487000Interwedge® Standalone LateralFoundation Surgical Group, Inc.2024-10-02OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810141046399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810141046399008101410463998101410463990810141046399

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

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
00810141047419Foundation Surgical VertiwedgeOV426600803OV4266008032026-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157074050ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074067ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074074ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074081ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074098ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074104ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074111ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074128ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074135ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074142ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074159ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074173ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074180ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074203ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074227ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074234ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074241ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074258ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074272ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074289ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074296ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074302ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074319ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074326ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074333ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29