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Proficient® Posterior Cervical Spine System

FDA UDI

Class II (US FDA UDI)

by Spine Wave, Inc.

Identity

Trade Name
Proficient® Posterior Cervical Spine System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Double Offset Connector, 3.5/4.0(O), 4.0 mm Rod × 11 mm FDA UDI
Model / Reference
11-9239 FDA UDI
Description
Double Offset Connector, 3.5/4.0(O), 4.0 mm Rod × 11 mm FDA UDI

Identifiers

Catalog Number
11-9239 FDA UDI
Primary DI / UDI-DI
10840642121292 FDA UDI
FDA Product Code
NKG FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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

No

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

Category: Bone-screw internal spinal fixation system connector

Proficient® Posterior Cervical Spine System by Spine Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spine Wave, Inc.

Sources (1)

  • FDA UDI 36c1ba47-c158-4245-8baa-db3e6f2d2dad 35 fields · synced Jun 1, 2026