FDA.report

iNSitu™ Hip System

Primary DI
00816127023293
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-95-3020
Device description
U-Joint Stem Extractor
Published
2023-09-01
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

Related Records

Contact Domains

Product Codes

CodeName
HWBExtractor

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816127023293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127023293008161270232938161270232930816127023293

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
10885862648143EquinoxeExactech, Inc.HWB2026-03-19
10885862660466N/AExactech, Inc.HWB2026-03-19
10885862663214N/AExactech, Inc.HWB2026-03-19
B922F00500380ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWB2026-03-11
00841435122574TecometTECOMET INC.HWB2026-02-27
07899258695174Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695181Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695198Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695204Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695211Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695228Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695235Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
03662663131759Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWB2026-02-11
00840338602497Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338602961Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338607799Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00840338607805Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00889024704008LB Type 1 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704015LZ 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704022LB 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704039Fitmore Extraction Adapter - MZimmer, Inc.HWB2025-12-18
00889024704046Fitmore Extraction Adapter - FZimmer, Inc.HWB2025-12-18
03662663274128Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-18
03662663217415Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217439Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217446Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217453Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217460Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663279277Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-16
10603295505044ATTUNEDEPUY (IRELAND)HWB2025-12-11