Monaco Pedicle Screw System 912-5100

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	Number00843210125343 UDI-DI	Date2 Oct 2018Listed	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Withdrawn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: Monaco Pedicle Screw System
Generic Name: Bone-screw internal spinal fixation system rod
Model / Reference: 912-5100

Primary DI / UDI-DI: 00843210125343
510(k) Number: K181339
FDA Product Code: KWQ, NKB
GMDN Term: Bone-screw internal spinal fixation system rod

Device Class: Class II
Regulation Number: 888.3060, 888.3070
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Length — 100 Millimeter
Outer Diameter — 5.5 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