FDA.report

iNSitu™ Hip System

Primary DI
00816127023958
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-96-0204
Device description
Lambotte Hook, Medium
Published
2023-09-05
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
KIKHook, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
KIKHook, BoneGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816127023958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127023958008161270239588161270239580816127023958

GMDN Terms

TermDefinition
Bone hookA hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. It is a shaft-like instrument with a robust design and can have a singular hook or multiple hooks at the distal end and a handle of various designs at the proximal end. It is made of high-grade stainless steel. It is sometimes called a bone retractor. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
330-733-7600info@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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