BKS E-Vitalize

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: BKS E-Vitalize FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: Size 1 16mm Tibial Insert PS, Vitamin E FDA UDI
Model / Reference: 166-5116 FDA UDI
Description: Size 1 16mm Tibial Insert PS, Vitamin E FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409006861 FDA UDI
510(k) Number: K131337 FDA UDI
FDA Product Code: JWH FDA UDI
OIY FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 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

Yes

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

Dimensions & Sizes

Size: Height — 16 Millimeter FDA UDI

Category: Tibial insert

BKS E-Vitalize by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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Cleared under the same submission

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: Ortho Development Corp.

Sources (1)

FDA UDI a08a3186-7a2f-48fb-948e-3f1df9fa73b3 36 fields · synced May 30, 2026