Pilot:gen A, Right

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: PILOT:GEN A,RIGHT FDA UDI
Generic Name: Vertebral body cement-containing implant FDA UDI
Model / Reference: PLT2100 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212023507 FDA UDI
510(k) Number: K141141 FDA UDI
FDA Product Code: LOD FDA UDI
GMDN Term: Vertebral body cement-containing implant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vertebral body cement-containing implant

Pilot:gen A, Right by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body cement-containing implant.

KIT:VCF TREATMENT, LEFT, FRACTURE — IZI MEDICAL PRODUCTS LLC · Class II
KIVA ULTRAFLEX CEMENT NEEDLE KIT — IZI MEDICAL PRODUCTS LLC · Class II
KIT:VCF TREATMENT, RIGHT, FRACTURE — IZI MEDICAL PRODUCTS LLC · Class II
KIVA INTRODUCER SET — IZI MEDICAL PRODUCTS LLC · Class II
PILOT:GEN A, LEFT — IZI MEDICAL PRODUCTS LLC · Class II

Cleared under the same submission

K141141 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Izi Medical Products Llc

Sources (1)

FDA UDI 40f62f52-fb1e-4670-9d1b-f2e60a8cc8f2 33 fields · synced May 30, 2026