FDA.reportPublic FDA data

Foundation Surgical Navigated Lateral Disc Prep

Primary DI
00810141048140
Brand
Foundation Surgical Navigated Lateral Disc Prep
Company
FOUNDATION SURGICAL GROUP INC
Model
NAV4680005
Catalog number
NAV4680005
Device description
Navlock Nav Cobb 20mm
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260011000Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.2026-04-16OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810141048140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810141048140008101410481408101410481400810141048140

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810141048072Foundation Surgical Navigated Lateral Disc PrepNAV2071NAV20712026-11-05
00810141048089Foundation Surgical Navigated Lateral Disc PrepNAV2072NAV20722026-11-05
00810141048096Foundation Surgical Navigated Lateral Disc PrepNAV2073NAV20732026-11-05
00810141048102Foundation Surgical Navigated Lateral Disc PrepNAV2074NAV20742026-11-05
00810141048126Foundation Surgical Navigated Lateral Disc PrepNAV4680022NAV46800222026-11-05
00810141048133Foundation Surgical Navigated Lateral Disc PrepNAV4680023NAV46800232026-11-05
00810141048157Foundation Surgical Navigated Lateral Disc PrepNAV4680024NAV46800242026-11-05
00810141048171Foundation Surgical Navigated Lateral Disc PrepNAV4680008NAV46800082026-11-05
00810141048225Foundation Surgical Navigated Lateral Disc Prep973465397346532026-11-05
00810141048232Foundation Surgical Navigated Lateral Disc Prep973465497346542026-11-05
00810141048249Foundation Surgical Navigated Lateral Disc Prep973465597346552026-11-05
00810141048256Foundation Surgical Navigated Lateral Disc Prep973465697346562026-11-05
00810141048263Foundation Surgical Navigated Lateral Disc Prep973465797346572026-11-05
00810141048270Foundation Surgical Navigated Lateral Disc Prep973465897346582026-11-05
00810141048287Foundation Surgical Navigated Lateral Disc Prep973465997346592026-11-05
00810141048294Foundation Surgical Navigated Lateral Disc Prep973466097346602026-11-05
00810141048300Foundation Surgical Navigated Lateral Disc Prep973466197346612026-11-05
00810141048317Foundation Surgical Navigated Lateral Disc Prep973466297346622026-11-05
00810141048324Foundation Surgical Navigated Lateral Disc Prep973466397346632026-11-05
00810141048331Foundation Surgical Navigated Lateral Disc Prep973466497346642026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141048072Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048089Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048096Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048102Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048126Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048133Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048157Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048171Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048225Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048232Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048249Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048256Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048263Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048270Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048287Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048294Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048300Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048317Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048324Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048331Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
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