Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1834179

FEI Number

1000160371

Entity Name

Haven Manufacturing

City/State/Country

OSSIAN, IN, US

Establishment Address

6935 N State Road 1, OSSIAN, IN 46777, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CADREX /Haven Manufacturing Indiana (Owner Number: 9008697)

Owner / Operator Contact Address

6935 N. State Road 1, Ossian, IN 46777, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NA (00889024197572) PINNACLE (10603295099093) NA (00889024197534) PINNACLE (10603295098966) PINNACLE (10603295098935) PINNACLE (10603295098959) PINNACLE (10603295098973) DEPUY (10603295084358) SELF CENTERING (10603295084501) PERSONA® Zimmer FuZion (00889024232273) PERSONA® Zimmer FuZion (00889024232259) DEPUY (10603295084334) PERSONA® Zimmer FuZion (00889024232266) DEPUY (10603295084341) NexGen® Legacy® (00889024226272) NA (00889024217836) NexGen® (00889024215887) NexGen® (00889024215849) NexGen® (00889024215856) NexGen® Trabucular Metal® (00889024208179) NexGen® (00889024201668) NexGen® (00889024207264) NA (00889024217843) NexGen® (00889024215863) NexGen® (00889024201675) NexGen® (00889024215825) NA (00889024217829) MICRO-MILL® (00889024213777) NA (00889024212985) NexGen® (00889024212794) NexGen® (00889024201644) NexGen® (00889024216600) NexGen® (00889024216549) SUMMIT (10603295143178) SUMMIT (10603295143185) AML EXCEL (10603295080008) AML EXCEL (10603295080015) AML EXCEL (10603295080022)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWA	Impactor	Orthopedic	Class 1	888.4540	2007-11-29
HXC	Wrench	Orthopedic	Class 1	888.4540	2018-08-20
HWT	Template	Orthopedic	Class 1	888.4800	2012-12-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-20
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-12-20
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2026-03-15

Official Correspondent

Leigh Chen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CADREX /Haven Manufacturing Indiana

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-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1834179. Last updated year: 2026. Please use registration number 1834179 when referencing this establishment in official correspondence.