Silverstone Titanium Interbody Fusion System ST52213

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	NumberB417ST522131 UDI-DI	Date22 Aug 2017Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Silverstone Titanium Interbody Fusion System
Generic Name: Polymeric spinal interbody fusion cage
Model / Reference: ST52213

Primary DI / UDI-DI: B417ST522131
510(k) Number: K170512
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

Sterilization Method: Moist Heat or Steam Sterilization

Size: Angle — 5 degree
Height — 13 Millimeter
Length — 22 Millimeter
Width — 10 Millimeter

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: No
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