FDA.report

iNSitu™ Hip System

Primary DI
00816127028809
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-80-0313
Device description
Blade Femoral Broach Size 13
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

Related Records

Contact Domains

Product Codes

CodeName
HTOReamer

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816127028809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127028809008161270288098161270288090816127028809

GMDN Terms

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
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

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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
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00816127025570TheRay Collared and Collarless Femoral Stem12-12-00062025-09-02
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00816127025600TheRay Collared and Collarless Femoral Stem12-12-00092025-09-02
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00816127025662TheRay Collared and Collarless Femoral Stem12-13-00022025-09-02
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