Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007593722

FEI Number

3007593722

Entity Name

MEDSHAPE, INC.

City/State/Country

Atlanta, GA, US

Establishment Address

1575 NORTHSIDE DR NW STE 440, Atlanta, GA 30318, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MedShape, Incorporated (Owner Number: 10026693)

Owner / Operator Contact Address

1575 Northside Drive NW STE 440, Atlanta, GA 30318, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140158

PMA Number

N/A

All Registered Proprietary Names

DynaNail Bone Punch Surgical Instruments and Accessories DynaNail TTC Tendon Shuttling Instrument Procedure Pack Transtibial Anterior Cruciate Ligament Kit Disposable Drill and Drill Guide Procedure Pack Tenodesis Accessory Instrument Procedure Pack EF1 External Fixation System Wrench Drills and Drill Guides Eclipse Soft Tissue Fastener DynaNail Hybrid DynaClip Delta Bone Staple DynaClip Quattro Bone Staple Evolve34 Correction Jig Evolve34 Joint Shim Evolve34 Joint Finder Evolve34 Instrument Sterilization Tray DynaFuse Fixation System EF1 External Fixation System DynaNail XL EF1 External Fixation System DynaNail Ankle Arthrodesis Intramedullary Nail EF1 External Fixation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2011-10-19
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-04-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-07-17
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-11-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-05-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2012-04-23
HXC	Wrench	Orthopedic	Class 1	888.4540	2023-11-06
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-04-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-09-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-09-03
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-09-14
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-05-17
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-05-17
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-04-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-04-12
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-11-06
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-11-30
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-11-06
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-10-10
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-11-06

Official Correspondent

Vladislava Zaitseva

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedShape, Incorporated

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
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K153770	In2bones Sas	OS2(R)-VP Varisation Staple	2016-03-21

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007593722. Last updated year: 2026. Please use registration number 3007593722 when referencing this establishment in official correspondence.