Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003597504

FEI Number

3003597504

Entity Name

RSB SPINE LLC.

City/State/Country

Wooster, OH, US

Establishment Address

1877 Eagle Pass, Wooster, OH 44691, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

RSB SPINE LLC. (Owner Number: 9048490)

Owner / Operator Contact Address

1877 EAGLE PASS, Wooster, OH 44691, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed rsb Redmed InterPlate InterPlate Spacer C-PS InterPlate Spacer L-PS InterPlate L-PS InterPlate C-PS Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed Redmed rsb Redmed InterPlate L-Ti InterPlate C-Ti InterPlate Redmed rsb Redmed Redmed Redmed Redmed Redmed Redmed Redmed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2025-02-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-01-15
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-02-03
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2025-02-03
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2025-02-03
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2025-01-15
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2008-11-04
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2025-02-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2010-10-06
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2010-10-06
FXG	Specula Accessories	General, Plastic Surgery	Class 1	878.1800	2025-02-03
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2025-02-03
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2025-01-15
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-01-15
HXR	Spatula, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2025-02-03
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-02-03
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2025-02-03
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2025-02-03
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2025-02-03
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2025-02-03
KTZ	Caliper	Orthopedic	Class 1	888.4150	2025-02-03
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2025-02-03
KAG	Holder, Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2025-02-03
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-02-03
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2008-11-04
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2008-11-04
HWA	Impactor	Orthopedic	Class 1	888.4540	2025-02-03
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2007-11-01
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2007-11-01
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2007-11-01
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2025-02-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2009-12-08
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2009-12-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
GXJ	Punch, Skull	Neurology	Class 1	882.4750	2025-01-15
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	2025-02-03
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2025-02-03
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-02-03

Official Correspondent

JOHN REDMOND

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RSB SPINE 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K041888	Signus Medizintechnik GmbH	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10
K211892	Arftx Medical, LLC	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	2022-10-06
K070082	Vertebration,Inc	XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY	2007-04-20

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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3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3000270450	Synthes GMBH	Selzach Solothurn, CH
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003597504. Last updated year: 2026. Please use registration number 3003597504 when referencing this establishment in official correspondence.