Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013413393

FEI Number

3013413393

Entity Name

Avalign Additive / Slice Manufacturing Studios

City/State/Country

Akron, OH, US

Establishment Address

1810 Triplett Blvd, Akron, OH 44306, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Avalign Instruments & Implants (Owner Number: 9008280)

Owner / Operator Contact Address

8727 Clinton Park Drive, --, Fort Wayne, IN 46825, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Prosthesis Tiger Shark System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	Orthopedic	Class 2	888.3353	2021-03-08
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-03-08
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	Orthopedic	Class 2	888.3358	2021-03-08
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-03-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-24
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-05-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avalign Instruments & Implants

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026776	VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, US
3006128100	Nemcomed FW LLC	FORT WAYNE, IN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2023	Zimmer, Inc.	2	G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

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3006801265	Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, CN
3043543260	FERRY MACHINE CORPORATION	Oakland, NJ, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013413393. Last updated year: 2026. Please use registration number 3013413393 when referencing this establishment in official correspondence.