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CyclaPlex Drill Bits 1.8-3.0

FDA UDI

Class II (US FDA UDI)

by Alphamet Ltd

Identity

Trade Name
CyclaPlex Drill Bits 1.8-3.0 FDA UDI
Generic Name
Fluted surgical drill bit, single-use, non-sterile FDA UDI
Device Name
The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant. FDA UDI
Model / Reference
V7 FDA UDI
Description
The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant. FDA UDI

Identifiers

Catalog Number
DB-9243 FDA UDI
Primary DI / UDI-DI
07290017626161 FDA UDI
510(k) Number
K183094 FDA UDI
FDA Product Code
HTN FDA UDI
GMDN Term
Fluted surgical drill bit, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 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

No

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: Fluted surgical drill bit, single-use, non-sterile

CyclaPlex Drill Bits 1.8-3.0 by Alphamet Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, single-use, non-sterile.

Cleared under the same submission

K183094 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphamet Ltd

Sources (1)

  • FDA UDI 5b461d3b-0e89-45c0-a223-52a469bae101 36 fields · synced May 31, 2026