Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044102

FEI Number

3013299874

Entity Name

XIROS LTD

City/State/Country

YEADON Leeds, GB

Establishment Address

SPRINGFIELD HOUSE, WHITEHOUSE LANE, YEADON Leeds LS19 7UE, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XIROS LTD (Owner Number: 9001185)

Owner / Operator Contact Address

SPRINGFIELD HOUSE, WHITEHOUSE LANE, YEADON, GB-LDS LS19 7UE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180243

PMA Number

N/A

All Registered Proprietary Names

sliding hammer SECURE LOOP 102-4015 SECURE LOOP 102-4035 SECURE LOOP 102-4010 SECURE LOOP 102-4025 SECURE LOOP 102-4045 SECURE LOOP 102-4040 SECURE LOOP 102-4060 SECURE LOOP 102-4020 SECURE LOOP 102-4050 SECURE LOOP 102-4030 SECURE LOOP 102-4055 Poly-Tape, 30 mm x 800 mm (open weave). 102-1083 102-1102 Infinity-Lock 7 mm x 400 mm 102-1100 Infinity-Lock 3 mm x 400 mm 102-1082 Poly-Tape 20 mm x 800 mm 102-1101 Infinity-Lock 5 mm x 400 mm 102-1087 Poly-Tape 7 mm x 800 mm 102-1080 Poly-Tape 10 mm x 800 mm 102-1086 Poly-Tape 5 mm x 800 mm 102-1081 Poly-Tape 15 mm x 800 mm Impactor Assembly. 202-1137 Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090 Pitch Patch Tissue Reinforcement 35mm x 25mm. 102-1091 TekBrace Solo, 25cm, 2470S025 TekBrace Solo, 12cm, 2470S012 FlexPasser Tendon Retrieval Kit. 202-1500 Pitch Patch Tissue Reinforcement 30mm x 20mm. 102-1090 Pitch Patch Tissue Reinforcement 35mm x 25mm. 102-1091 Malleable Probe Rigid Probe 102-1143 AchilloCordPLUS 10050 SIC Graft 102-1082 Poly-Tape 20 mm x 800 mm 102-1102 Infinity-Lock 7 mm x 400 mm 102-1100 Infinity-Lock 3 mm x 400 mm 102-1087 Poly-Tape 7 mm x 800 mm 102-1101 Infinity-Lock 5 mm x 400 mm 102-1080 Poly-Tape 10 mm x 800 mm 102-1081 Poly-Tape 15 mm x 800 mm 102-1086 Poly-Tape 5 mm x 800 mm MWEB5040 FORCEWEB 5 mm x 500 mm 102-1005 Poly-Tape 5 mm x 500 mm 102-1083 Poly-Tape 30 mm x 800 mm Infinity-Lock Button System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWB	Extractor	Orthopedic	Class 1	888.4540	2004-08-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-10-09
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2008-01-18
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-09-28
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2022-09-28
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2004-08-12
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2021-08-19
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-08-14
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2025-08-14
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-08-14
HWQ	Passer	Orthopedic	Class 1	888.4540	2019-09-24
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-08-08
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2023-08-08
HXB	Probe	Orthopedic	Class 1	888.4540	2022-09-01
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-04
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	General, Plastic Surgery	Class 2	878.3300	2023-01-04
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2023-01-04
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-05-16

Official Correspondent

Derrick White

US Agent Details

Ken Carrier Business: KEC Consulting Email: ken@kecconsulting.com Phone: (781) 2465220

Related Public Records

Same Entity

XIROS LTD

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
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

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3008744062	Smith & Nephew, Inc.	Cordova, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044102. Last updated year: 2026. Please use registration number 8044102 when referencing this establishment in official correspondence.