Endoskeleton® to 3200-4000

by Medtronic Sofamor Danek, 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	Number00191375004882 UDI-DI	Date15 Dec 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Endoskeleton® to
Generic Name: Orthopaedic inorganic implant inserter/extractor, reusable
Model / Reference: 3200-4000

Primary DI / UDI-DI: 00191375004882
FDA Product Code: HWB
GMDN Term: Orthopaedic inorganic implant inserter/extractor, reusable

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

Sterilization Method: Moist Heat or Steam Sterilization

Size: Length — 13 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