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Intervertebral Body Fusion Device

FDA UDI

Class I (US FDA UDI)

by Precision Spine, Inc.

Identity

Trade Name
Intervertebral Body Fusion Device FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
12mm 10 degree O TPLIF Sizer FDA UDI
Model / Reference
44-910-12 FDA UDI
Description
12mm 10 degree O TPLIF Sizer FDA UDI

Identifiers

Catalog Number
44-910-12 FDA UDI
Primary DI / UDI-DI
00840019924184 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

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: Orthopaedic surgical procedure kit, non-medicated, reusable

Intervertebral Body Fusion Device by Precision Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Spine, Inc.

Sources (1)

  • FDA UDI 503b97e2-eafb-4c95-bd79-7cd0a6616724 34 fields · synced May 30, 2026