Spinal Distractor 416-604

by Sontec Instruments, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00192896037588 UDI-DI	Date13 Sep 2018Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Spinal Distractor
Generic Name: Orthopaedic surgical distractor, internal
Model / Ref / Catalog: 416-604

Primary DI / UDI-DI: 00192896037588
FDA Product Code: HWN
GMDN Term: Orthopaedic surgical distractor, internal

Device Class: Class I
Regulation Number: 888.4540
GUDID distribution status: In Commercial Distribution

Size: Length — 11.25 Inch

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No