CLYDESDALE PTC™ Spinal System 4920650

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00643169190894 UDI-DI	Date3 Apr 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: CLYDESDALE PTC™ Spinal System
Generic Name: Polymeric spinal interbody fusion cage
Model / Reference: 4920650

Primary DI / UDI-DI: 00643169190894
510(k) Number: K133205
FDA Product Code: MAX
GMDN Term: Polymeric spinal interbody fusion cage

Device Class: Class II
Regulation Number: 888.3080
GUDID distribution status: In Commercial Distribution

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (9)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No