icotec Pedicle System Cross-Link, Ti 33/42 mm

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 16-57-93442

by icotec ag

Identity

Trade Name: icotec Pedicle System Cross-Link, Ti 33/42 mm EUDAMED
icotec Pedicle System, Cross-Link, Ti, 33/42 mm FDA UDI
Generic Name: Bone-screw internal spinal fixation system connector FDA UDI
Device Name: Pedicle System Cross Link (Ti) EUDAMED
icotec Pedicle System, Cross-Link, Ti, 33/42 mm FDA UDI
Model / Reference: 16-57-93442 EUDAMEDFDA UDI
Description: icotec Pedicle System, Cross-Link, Ti, 33/42 mm FDA UDI

Identifiers

Catalog Number: 16-57-93442 FDA UDI
Primary DI / UDI-DI: 07640164846286 EUDAMEDFDA UDI
Basic UDI-DI: 764017255PSICONTi001H8 EUDAMED
FDA Product Code: NKB FDA UDI
PML FDA UDI
EMDN Code: P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term: Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3027 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Spinal bone screw, non-bioabsorbable

icotec Pedicle System Cross-Link, Ti 33/42 mm by icotec AG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K151977	Class IIb	Active
EUDAMED	European Union	CE/MDR	764017255PSICONTi001H8	Class IIb	Active

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Manufacturer

Manufacturer: icotec ag
EUDAMED SRN: CH-MF-000026833
Authorised Representative: icotec Medical GmbH DE-AR-000016837

Sources (3)

EUDAMED eef066c0-27cb-413c-908c-f6cbe2a4e7dc 61 fields · synced Jul 13, 2026
FDA UDI 5656854d-0888-410b-a1c0-5dd9aab95b58 35 fields · synced May 29, 2026
FDA 510(k) K151977 1 fields · synced May 18, 2026