FDA.reportPublic FDA data

Foundation Surgical Instruments

Primary DI
00810141040007
Brand
Foundation Surgical Instruments
Company
FOUNDATION SURGICAL GROUP INC
Model
FS50-010000
Catalog number
FS50-010000
Device description
Staple Rotator
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00810141040007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810141040007008101410400078101410400070810141040007

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
119029419
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810141040892Foundation Surgical InstrumentsFSN-5400002026-10-22
00810141040908Foundation Surgical InstrumentsFSN-570000FSN-5700002026-10-22
00810141040915Foundation Surgical InstrumentsFSN-575000FSN-5750002026-10-22
00810141040953Foundation Surgical InstrumentsFSN-312000FSN-3120002026-10-22
00810141040977Foundation Surgical InstrumentsFS50-351000FS50-3510002026-10-22
00810141047532Foundation Surgical InstrumentsFSN-170000FSN-1700002026-10-22
00810141047549Foundation Surgical InstrumentsFSN-700018FSN-7000182026-10-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606187626Ventana ASPINAL ELEMENTS, INC.OVD2026-10-22
10889981217204MeridianSeaspine Orthopedics CorporationOVD2022-08-25
10889981230906RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230913RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230920RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230937RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230944RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230951RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230968RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230975RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230982RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981230999RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231002RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231019RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231026RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231033RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231248RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231255RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231262RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981231279RegattaSeaspine Orthopedics CorporationOVD2021-02-02
10889981214395MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214425MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214432MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214449MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214456MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214463MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214470MeridianSeaspine Orthopedics CorporationOVD2020-12-30
10889981214487MeridianSeaspine Orthopedics CorporationOVD2020-12-30