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NorthStar

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
NorthStar FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Contoured CoCr Rod, 4.0mm x 55mm FDA UDI
Model / Reference
PC1-514055 FDA UDI
Description
Contoured CoCr Rod, 4.0mm x 55mm FDA UDI

Identifiers

Catalog Number
PC1-514055 FDA UDI
Primary DI / UDI-DI
10889981198909 FDA UDI
510(k) Number
K193615 FDA UDI
FDA Product Code
NKG FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3075 FDA UDI
888.3050 FDA UDI
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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

NorthStar by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Cleared under the same submission

K193615 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI 115f04db-b579-405e-9e2a-c0fa0e1ff81a 36 fields · synced Jun 8, 2026