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VyWasher™

FDA UDI

Class II (US FDA UDI)

by Vy Spine Llc

Identity

Trade Name
VyWasher™ FDA UDI
Generic Name
Vertebral body bone graft positioning plate FDA UDI
Device Name
Washer, 15x20mm, Ti 6Al-4V FDA UDI
Model / Reference
12-WA-1520-TI-N FDA UDI
Description
Washer, 15x20mm, Ti 6Al-4V FDA UDI

Identifiers

Primary DI / UDI-DI
00840283400384 FDA UDI
510(k) Number
K213219 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Vertebral body bone graft positioning plate FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Vertebral body bone graft positioning plate

VyWasher™ by Vy Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body bone graft positioning plate.

Cleared under the same submission

K213219 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vy Spine Llc

Sources (1)

  • FDA UDI 68faa20e-9022-4d26-8599-d96890ad6f16 35 fields · synced May 30, 2026