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Sagittae

FDA UDI

Class II (US FDA UDI)

by Spineex, Inc.

Identity

Trade Name
Sagittae FDA UDI
Generic Name
Surgical instrument handle, torque-limiting FDA UDI
Device Name
Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.25 Nm FDA UDI
Model / Reference
901-030-01 FDA UDI
Description
Torque Limiting Handle, 1/4" SQ ADPT, Ratchet, Sagittae, Inserter, 2.25 Nm FDA UDI

Identifiers

Catalog Number
901-030-01 FDA UDI
Primary DI / UDI-DI
00819837020446 FDA UDI
510(k) Number
K181531 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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: Surgical instrument handle, torque-limiting

Sagittae by Spineex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

Cleared under the same submission

K181531 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineex, Inc.

Sources (1)

  • FDA UDI 7548b47b-e778-49e4-bd2f-9215b3d346a2 36 fields · synced May 31, 2026