Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011307621

FEI Number

3011307621

Entity Name

LENKBAR LLC

City/State/Country

Naples, FL, US

Establishment Address

2705 Corporate Flight Drive, Naples, FL 34104, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lenkbar LLC (Owner Number: 10048183)

Owner / Operator Contact Address

89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthopedic manual surgical instrument Flex metric Drill 45135-66H-17 Med 4.5 X 66 mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2014-12-15
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-03-07
HTO	Reamer	Orthopedic	Class 1	888.4540	2015-03-20

Official Correspondent

Lisa Boyle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lenkbar LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3005706667	TURNER MEDICAL INC.	Athens, AL, US
3011577940	Titan Spine, a Division of Medtronic	Milwaukee, WI, US
2031917	CLASSIC WIRE CUT COMPANY, INC.	Valencia, CA, US
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011307621. Last updated year: 2026. Please use registration number 3011307621 when referencing this establishment in official correspondence.