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KINCISE™ System Acetabular Cup Extraction Starter Blade 58mm

FDA UDI

Class I (US FDA UDI)

by Spierings Orthopaedics B.V.

Identity

Trade Name
KINCISE™ System Acetabular Cup Extraction Starter Blade 58mm FDA UDI
Generic Name
Orthopaedic osteotome blade, single-use FDA UDI
Model / Reference
KIN-2110-58S-SU FDA UDI

Identifiers

Catalog Number
200005158 FDA UDI
Primary DI / UDI-DI
08720254007328 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Orthopaedic osteotome blade, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic osteotome blade, single-use

KINCISE™ System Acetabular Cup Extraction Starter Blade 58mm by Spierings Orthopaedics B.V. — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Orthopaedic osteotome blade, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spierings Orthopaedics B.V.

Sources (1)

  • FDA UDI e3742fc5-4324-4c4a-af12-1b03b7eefa23 33 fields · synced May 30, 2026