FDA.reportPublic FDA data

Newclip Instruments

Primary DI
03700569642174
Brand
Newclip Instruments
Company
NEWCLIP TECHNICS
Model
ANC970
Catalog number
ANC970
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
03700569642174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569642174037005696421743700569642174

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Regulatory Flags#

DUNS number
263281904
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569638306NASAT3.5L22SAT3.5L222024-11-15
03700569638313NASAT3.5L22-STSAT3.5L22-ST2024-11-15
03700569638320NASAT3.5L24SAT3.5L242024-11-15
03700569638337NASAT3.5L24-STSAT3.5L24-ST2024-11-15
03700569638344NASAT3.5L26SAT3.5L262024-11-15
03700569638351NASAT3.5L26-STSAT3.5L26-ST2024-11-15
03700569638368NASAT3.5L28SAT3.5L282024-11-15
03700569638375NASAT3.5L28-STSAT3.5L28-ST2024-11-15
03700569638382NASAT3.5L30SAT3.5L302024-11-15
03700569638399NASAT3.5L30-STSAT3.5L30-ST2024-11-15
03700569638405NASAT3.5L32SAT3.5L322024-11-15
03700569638412NASAT3.5L32-STSAT3.5L32-ST2024-11-15
03700569638429NASAT3.5L36SAT3.5L362024-11-15
03700569638436NASAT3.5L36-STSAT3.5L36-ST2024-11-15
03700569638443NASAT3.5L38SAT3.5L382024-11-15
03700569638450NASAT3.5L38-STSAT3.5L38-ST2024-11-15
03700569638467NASAT3.5L40SAT3.5L402024-11-15
03700569638474NASAT3.5L40-STSAT3.5L40-ST2024-11-15
03700569648770NASAT3.5L34SAT3.5L342024-11-15
03700569648787NASAT3.5L34-STSAT3.5L34-ST2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
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00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
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08800017276182LOSPACorentec Co., LtdLXH2026-10-29
08806373878039LOSPACorentec Co., LtdLXH2026-10-29
08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28