FDA.reportPublic FDA data

iNSitu™ Hip System

Primary DI
00816127021688
Brand
iNSitu™ Hip System
Company
NEXTSTEP ARTHROPEDIX, LLC
Model
10-95-2027
Device description
Angled Depth Gauge
Published
2023-09-01
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816127021688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816127021688008161270216888161270216880816127021688

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced; or 3) a cylindrical rod with markings. This is a single-use 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
00810030810575InSitu Hip System10-83-04572026-06-01
00810030810582InSitu Hip System10-83-04582026-06-01
00810030810599InSitu Hip System10-83-04592026-06-01
00810030810605InSitu Hip System10-83-04602026-06-01
00810030810612InSitu Hip System10-83-04612026-06-01
00810030810629InSitu Hip System10-83-04622026-06-01
00810030810636InSitu Hip System10-83-04632026-06-01
00810030810643InSitu Hip System10-83-04642026-06-01
00810030810650InSitu Hip System10-83-04652026-06-01
00810030810667InSitu Hip System10-83-04662026-06-01
00810030810674InSitu Hip System10-83-04672026-06-01
00810030810681InSitu Hip System10-83-04682026-06-01
00810030810698InSitu Hip System10-83-04692026-06-01
00810030810704InSitu Hip System10-83-04702026-06-01
00810030811657InSitu Hip System10-95-2081-452026-06-01
00810030811671InSitu Hip System10-95-2081-602026-06-01
00810030811992InSitu Hip System10-85-36482026-06-01
00810030812036InSitu Hip System10-84-20422026-06-01
00810030812043InSitu Hip System10-84-20442026-06-01
00810030812050InSitu Hip System10-84-20462026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00190446960317Active AdaptiveMedshape, Inc.LXH2026-10-09
00190446960355DYNANAIL HELIXMedshape, Inc.LXH2026-10-09
00190446960393DYNANAIL HELIXMedshape, Inc.LXH2026-10-09
00198506095771ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00198506095788ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00810155330781Tigon MedicalTigon Medical LLCLXH2026-10-09
08056711926636Orthopaedic Manual Surgical InstrumentsCITIEFFE SRLLXH2026-10-09
08809986489753LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489760LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489777LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
00190776433666MillenniumAvalign Technologies, Inc.LXH2026-10-07
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00810055525751Onyx Dual End Set Screw StarterSi-Bone Inc.LXH2026-10-06
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00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
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M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01