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Skyline

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 286820014Model Skyline Orthopaedic Surgery Cutting Instruments

by Depuy Spine, Inc.

Identity

Trade Name
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EUDAMED
SKYLINE FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
Skyline Drill EUDAMED
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 x 14mm FDA UDI
Model / Reference
286820014 EUDAMEDFDA UDI
Skyline Orthopaedic Surgery Cutting Instruments EUDAMED
Description
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 x 14mm FDA UDI

Identifiers

Catalog Number
286820014 FDA UDI
Primary DI / UDI-DI
10705034215310 EUDAMEDFDA UDI
Basic UDI-DI
0705034a0009467 EUDAMED
Direct Marketing DI
10705034215310 EUDAMED
FDA Product Code
HTW FDA UDI
EMDN Code
Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Skyline by Depuy Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (2)

  • FDA UDI ad6cc02d-156a-48ae-9220-0820e4181aff 35 fields · synced Oct 7, 2026
  • EUDAMED 624871c4-3241-4126-81ec-a114518abfad 61 fields · synced Jul 29, 2026