FDA.reportPublic FDA data

PSI

Primary DI
03700569619459
Brand
PSI
Company
NEWCLIP TECHNICS
Model
ANC656
Catalog number
ANC656
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243912000Newclip Patient-matched instrumentation non sterile PSINewclip Technics2025-02-13PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569619459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569619459037005696194593700569619459

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, single-useA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370056966354NARDT2.8L38D-STRDT2.8L38D-ST2026-07-28
03700569628253NACT3.5L20D-STCT3.5L20D-ST2026-07-28
03700569628277NACT3.5L22D-STCT3.5L22D-ST2026-07-28
03700569641269NAH1.3GLT4.0L70DH1.3GLT4.0L70D2026-07-28
03700569644451NASOT3.5L10DSOT3.5L10D2026-07-28
03700569644468NASOT3.5L12DSOT3.5L12D2026-07-28
03700569644475NASOT3.5L14DSOT3.5L14D2026-07-28
03700569644482NASOT3.5L16DSOT3.5L16D2026-07-28
03700569644499NASOT3.5L18DSOT3.5L18D2026-07-28
03700569644505NASOT3.5L20DSOT3.5L20D2026-07-28
03700569644512NASOT3.5L22DSOT3.5L22D2026-07-28
03700569644529NASOT3.5L24DSOT3.5L24D2026-07-28
03700569644581NACT3.5L20DCT3.5L20D2026-07-28
03700569644598NACT3.5L22DCT3.5L22D2026-07-28
03700569644611NACT3.5L26DCT3.5L26D2026-07-28
03700569652555NACT3.5L32DCT3.5L32D2026-07-28
03700569654757NACT3.5L40DCT3.5L40D2026-07-28
03700569657727NACT2.8L16DCT2.8L16D2026-07-28
03700569657963NACT2.8L40DCT2.8L40D2026-07-28
03700569659219Alians Elbow SNTGY1DNTGY1D2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncPBF2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
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