Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026035863

FEI Number

3026035863

Entity Name

SKELETAL DYNAMICS STRATEGIC MANUFACTURING CENTER

City/State/Country

Bonita Springs, FL, US

Establishment Address

28041 Trade Way Two, Unit 1, Bonita Springs, FL 34135, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Skeletal Dynamics Strategic Manufacturing Center, LLC (Owner Number: 10087105)

Owner / Operator Contact Address

28041 Trade Way Two, Unit 1, Bonita Springs, FL 34135, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Skeletal Dynamics Strategic Manufacturing Center Skeletal Dynamics Strategic Manufacturing Center

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-12

Official Correspondent

Daniel Ennis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Skeletal Dynamics Strategic Manufacturing Center, LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3017609305	PRIMEMED INC.	Sungnam-city Gyeonggi, KR
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026035863. Last updated year: 2026. Please use registration number 3026035863 when referencing this establishment in official correspondence.