Pilot:gen A, Left

FDA UDI

Class II (US FDA UDI)

by Izi Medical Products Llc

Identity

Trade Name: PILOT:GEN A,LEFT FDA UDI
Generic Name: Vertebral body cement-containing implant FDA UDI
Model / Reference: PLT2200 FDA UDI

Identifiers

Primary DI / UDI-DI: 00815212023514 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, Left 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
PILOT:GEN A, RIGHT — 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Izi Medical Products Llc

Sources (1)

FDA UDI a79b1bb4-e542-4cf9-86cd-26844d1fc8be 33 fields · synced Jun 7, 2026