Kasm

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: KASM FDA UDI
Generic Name: Orthopaedic cement spacer mould FDA UDI
Device Name: Medium 45A/P x 70M/L Tibial Spacer Mold FDA UDI
Model / Reference: 669-2070 FDA UDI
Description: Medium 45A/P x 70M/L Tibial Spacer Mold FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409007592 FDA UDI
510(k) Number: K133449 FDA UDI
FDA Product Code: JWH FDA UDI
MBB FDA UDI
GMDN Term: Orthopaedic cement spacer mould FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3027 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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: Width — 70 Millimeter FDA UDI
Length — 45 Millimeter FDA UDI

Category: Orthopaedic cement spacer mould

Kasm by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement spacer mould.

Cellbrick Knee Spacer — UNITED ORTHOPEDIC CORP. · Class I
STAGEONE — Biomet Orthopedics, Inc. · Class II
StageOne Select — Biomet Orthopedics, Inc. · Class II
CeMend 10-48 mold insert press — G21 SRL · Class II
CEMENTON — Biomet Orthopedics, Inc. · Class II
CeMend Shoulder Spacer Mold — G21 SRL · Class II
STAGEONE SELECT — Biomet Orthopedics, Inc. · Class II
CEMENTON — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K133449 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: Ortho Development Corp.

Sources (1)

FDA UDI 908ea25b-4914-4e99-972d-be6bc3485762 36 fields · synced Jun 8, 2026