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Synster Pedicle Screw System Synster Plus Pedicle Screw System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K120353

by Bm Korea Co., Ltd

Identity

Trade Name
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case. FDA UDI
Model / Reference
A1P1-7555 FDA UDI
Description
The Pedicle Screw Spinal Fixation Systemconsists of a variety of shapes and sizes of rods, screws, and cross links which can be rigidly locked into a variety of configurations, made for the individual case. FDA UDI

Identifiers

Primary DI / UDI-DI
08809255540758 FDA UDI
510(k) Number
K120353 FDA 510(k)FDA UDI
FDA Product Code
MNH FDA 510(k)FDA UDI
MNI FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile 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

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 55 Millimeter FDA UDI
Outer Diameter — 7.5 Millimeter FDA UDI

Synster Pedicle Screw System Synster Plus Pedicle Screw System by Bm Korea Co., Ltd — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bm Korea Co., Ltd
FDA Applicant
Bm Korea Co., Ltd.

Sources (2)

  • FDA 510(k) K120353 24 fields · synced Jun 18, 2026
  • FDA UDI 33ba1006-c3fe-42b1-be47-7e3541c05395 35 fields · synced May 26, 2026