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Impactor – 4.0 mm

FDA UDI

Class I (US FDA UDI)

by Si-Bone Inc.

Identity

Trade Name
Impactor – 4.0 mm FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
Device Name
Impactor – 4.0 mm FDA UDI
Model / Reference
500085 FDA UDI
Description
Impactor – 4.0 mm FDA UDI

Identifiers

Primary DI / UDI-DI
00851085007985 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

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: Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Impactor – 4.0 mm by Si-Bone Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint transarticular fixation/arthrodesis implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Si-Bone Inc.

Sources (1)

  • FDA UDI aeb683aa-fbdc-4cac-883a-a95ee121d7c0 34 fields · synced May 30, 2026