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Iliac Screws

FDA UDI

Class II (US FDA UDI)

by Shandong Weigao Orthopaedic Device Co., Ltd.

Identity

Trade Name
Iliac Screws FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Model / Reference
803531085 FDA UDI

Identifiers

Primary DI / UDI-DI
06912547300663 FDA UDI
510(k) Number
K160320 FDA UDI
FDA Product Code
MNH FDA UDI
KWP FDA UDI
MNI FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Iliac Screws by Shandong Weigao Orthopaedic Device Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K160320 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd.

Sources (1)

  • FDA UDI ae032f16-dd24-4d4d-bf65-02b87617646c 34 fields · synced Jun 8, 2026