FDA.reportPublic FDA data

iNSitu™ Hip System

Primary DI
00816127028762
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-80-0309
Device description
Blade Femoral Broach Size 9
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00816127028762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127028762008161270287628161270287620816127028762

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
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
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