FDA.reportPublic FDA data

iNSitu™ Hip System

Primary DI
00816127020049
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-80-0003
Device description
Femoral Broach Size 3
Published
2023-08-29
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
HTQBroach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816127020049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127020049008161270200498161270200490816127020049

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3307337600info@theken.us

Regulatory Flags#

DUNS number
060211165
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816127025518TheRay Collared and Collarless Femoral Stem12-12-00002025-09-02
00816127025525TheRay Collared and Collarless Femoral Stem12-12-00012025-09-02
00816127025532TheRay Collared and Collarless Femoral Stem12-12-00022025-09-02
00816127025549TheRay Collared and Collarless Femoral Stem12-12-00032025-09-02
00816127025556TheRay Collared and Collarless Femoral Stem12-12-00042025-09-02
00816127025563TheRay Collared and Collarless Femoral Stem12-12-00052025-09-02
00816127025570TheRay Collared and Collarless Femoral Stem12-12-00062025-09-02
00816127025587TheRay Collared and Collarless Femoral Stem12-12-00072025-09-02
00816127025594TheRay Collared and Collarless Femoral Stem12-12-00082025-09-02
00816127025600TheRay Collared and Collarless Femoral Stem12-12-00092025-09-02
00816127025617TheRay Collared and Collarless Femoral Stem12-12-00102025-09-02
00816127025648TheRay Collared and Collarless Femoral Stem12-13-00002025-09-02
00816127025655TheRay Collared and Collarless Femoral Stem12-13-00012025-09-02
00816127025662TheRay Collared and Collarless Femoral Stem12-13-00022025-09-02
00816127025679TheRay Collared and Collarless Femoral Stem12-13-00032025-09-02
00816127025686TheRay Collared and Collarless Femoral Stem12-13-00042025-09-02
00816127025693TheRay Collared and Collarless Femoral Stem12-13-00052025-09-02
00816127025709TheRay Collared and Collarless Femoral Stem12-13-00062025-09-02
00816127025716TheRay Collared and Collarless Femoral Stem12-13-00072025-09-02
00816127025723TheRay Collared and Collarless Femoral Stem12-13-00082025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889797112307Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00889797112314Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00810111222679BroachTreace Medical Concepts, Inc.HTQ2025-08-06
00822409130962N/AOrtho Development CorporationHTQ2025-06-25
00822409130979N/AOrtho Development CorporationHTQ2025-06-25
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
00840286841740Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841757Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841764Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841771Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841788Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841795Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841801Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841818Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841825Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841832Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841849Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841856Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841863Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841870Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841887Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841894Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286840491TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840507TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840514TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840521TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840538TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840545TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840552Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840569TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21