Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002719998

FEI Number

3002719998

Entity Name

RTI Surgical, Inc. (dba RTI Biologics, Inc.)

City/State/Country

ALACHUA, FL, US

Establishment Address

11621 Research Circle, ALACHUA, FL 32615, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RTI Surgical, Inc. (dba RTI Biologics, Inc.) (Owner Number: 1641375)

Owner / Operator Contact Address

11621 Research Circle, Alachua, FL 32615, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Caliper component of Precision Allograft Cartilage Kit (PACK) Instrument Set - Ruler, for estimating size component of Fresh OC Instrument Set - Vise component of MAT Instrument Set - Plug Station component of Fresh OC Instrument Set RapidEase component of Meniscus Allograft Instrument Kit General Instruments component of Fresh OC Instrument Set component of Precision Allograft Cartilage Kit (PACK) Instrument Set component of AlloWedge® Instrument Set component of MAT Instrument Set Tutomesh® Bovine Pericardium Tutopatch® Bovine Pericardium CANCELLO-PURE® Wedge CopiOs® Cancellous Chips, Cancellous Cubes & Wedge Sterling® Cancellous Chips, Cancellous Cubes, & Wedge Regenavate Regenaform Regenafil AlloSculpt-3D Plus component of Sterling® Interference Screw Instrument Kit component of MAT Instrument Set Sterling® Interference Screw HT RapidEase Pre-Sutured Tendon Tutopatch DM Graft Tutoplast Bovine Pericardium DM Bovine Pericardium Suturable Dural Graft component of Sterling® Interference Screw Instrument Kit component of MAT Instrument Set RTI Allograft Paste ProSpace DBM-D Altiva DBM BioSet® paste Opteform® paste Osteofil® paste Synergent DBM with CCC Sterling® Interference Screw HT Sterling® Interference Screw ST component of AlloWedge® Instrument Set component of dbm product accessory kit -Coupling, component of coring station -Carriage break, component of coring station -Base Plate, component of coring station -Coring Reamers -Long pivot arm, component of coring station component of Precision Allograft Cartilage Kit (PACK) Instrument Set component of Fresh OC Instrument Set -Carriage, component of coring station -Short pivot arm, component of coring station -Coring Station, componenet of coring reamer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2009-08-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-12-02
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Orthopedic	Class 2	888.3045	2008-12-02
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2009-08-04
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-12-09
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-12-27
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-12-02
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2009-08-04
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2009-08-04
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2009-08-04
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2009-08-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-12-02
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2008-12-02
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2008-12-02
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2009-08-04
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-12-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-12-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-12-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-10-17
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2014-04-07
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2008-12-02
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2012-12-27
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2008-12-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-12-02
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2013-07-22
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-12-02
HTO	Reamer	Orthopedic	Class 1	888.4540	2009-08-05

Official Correspondent

Rosanne Lopez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RTI Surgical, Inc. (dba RTI Biologics, Inc.)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002924436	Tutogen Medical GmBH	Neunkirchen am Brand Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180121	Cellumed Co., Ltd.	Rafugen DBM	2018-04-11
K062691	Takiron Co., Ltd.	COMPORUS	2008-04-15
K023703	Berkeley Advanced Biomaterials, Inc.	BI-OSTETIC	2003-01-30
K173933	Xenco Medical, LLC	Sorrento Bioglass Bone Graft Substitute	2018-09-13
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

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
3007031057	MERCIAN SURGICAL SUPPLY CO LTD	Bromsgrove Worcestershire, GB
3011693567	LAMINATE MEDICAL TECHNOLOGIES	Tel Aviv, IL
3009134882	DMED	Seongnam-si Gyeonggi, KR
1057425	SOUTHEASTERN TECHNOLOGY dba Autocam Medical	Murfreesboro, TN, US
8044098	HGR INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002719998. Last updated year: 2026. Please use registration number 3002719998 when referencing this establishment in official correspondence.