← Back to catalogue

Crossway

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name
CROSSWAY FDA UDI
Generic Name
Spinal bone screw, bioabsorbable FDA UDI
Device Name
Temporary Fixation Screw, 10mm FDA UDI
Model / Reference
6177.1010S FDA UDI
Description
Temporary Fixation Screw, 10mm FDA UDI

Identifiers

Primary DI / UDI-DI
00889095998634 FDA UDI
510(k) Number
K190598 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Spinal bone screw, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 10 Millimeter FDA UDI

Category: Spinal bone screw, bioabsorbable

Crossway by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, bioabsorbable.

Cleared under the same submission

K190598 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Globus Medical, Inc.

Sources (1)

  • FDA UDI 8c7ee8e5-2ad6-40fc-816f-4f470dfd768d 36 fields · synced May 30, 2026