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Dvx Spine System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K080876

by Bk Meditech Co., Ltd.

Identity

Trade Name
DVX SPINE SYSTEM FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Multi-axial Pedicle Screw, Ø5.5 x 40mm FDA UDI
Model / Reference
81255-40 FDA UDI
Description
Multi-axial Pedicle Screw, Ø5.5 x 40mm FDA UDI

Identifiers

Primary DI / UDI-DI
08809155852098 FDA UDI
510(k) Number
K080876 FDA 510(k)FDA UDI
FDA Product Code
MNH FDA 510(k)FDA UDI
MNI FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Dvx Spine System by Bk Meditech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bk Meditech Co., Ltd.
FDA Applicant
Bk Meditech, Co., Ltd.

Sources (2)

  • FDA 510(k) K080876 24 fields · synced Jun 18, 2026
  • FDA UDI 2aa3f564-d255-4973-a4be-9ca60828eec3 34 fields · synced May 27, 2026