Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221934

FEI Number

1221934

Entity Name

DePuy Mitek, Inc.

City/State/Country

RAYNHAM, MA, US

Establishment Address

325 Paramount Dr, RAYNHAM, MA 02767, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY (Owner Number: 1221934)

Owner / Operator Contact Address

4600 Riverside Drive, --, Palm Beach Gardens, FL 33410, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K000936

PMA Number

N/A

All Registered Proprietary Names

PUREVUE DELTA CTA Shoulder System SlingShot GLOBAL AP GLOBAL APG GLOBAL SHOULDER Biocryl Rapide Interference Screw HEALIX ADVANCE Anchor with DYNACORD Suture GLOBAL CAP BioFastin RC Anchor DELTA XTEND Reverse Shoulder System GLOBAL AP GLOBAL ADVANTAGE GLOBAL UNITE DELTA CTA Shoulder System GLOBAL APG+ TALON ANCHOR SNAP-PAK NEUFLEX Fastin Anchor MULTIPLE CANNULAE FMS ARTHROSCOPY WORKING CANNULA Gryphon Anchor w/ProKnot Bio-Intrafix Screw/Sheath DELTA XTEND Reverse Shoulder System GLOBAL ADVANTAGE GLOBAL ENABLE Milagro/Milagro Advance Screw Anchor DePuy Mitek Instrument RIGIDFIX BTB Cross Pin Kit ROC P50 NEUFLEX FMS Cannula RigidFix PLA GII QA+ w #2 Orthocord DELTA XTEND Reverse Shoulder System DELTA XTEND Reverse Shoulder System Clearfix Meniscal Screw Healix Advance Anchors with Permacord Suture Quickanchor HEALIX ADVANCE SP PEEK Anchor Rigidloop Titanium Button Rigidloop Cortical Fixation System XL Implant CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TIS Global Unite Platform Shoulder System duo+ and solo ARTHROSCOPE (MULTIPLE BRANDS) AGILITY RigidLoop NEUFLEX RigidLoop Adjustable Cortical Fixation System Super Anchor Healix Ti HEALIX ADVANCE Knotless Anchors HEALIX ADVANCE Self-Punching Anchors GLOBAL ADVANTAGE GLOBAL APG+ GLOBAL UNITE Screw RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM GII ROC EZ PERMATAPE SUTURE CUTTER Milagro Interference Screws Gryphon Anchors MiniROC SINUSCOPE Healix Advance Knotless BR Anchor Rigidloop Disposable Kit GLOBAL STEPTECH RigidFix Biocryl Cross Pin Kit INHANCE Shoulder System VAPR II Generator & TC Electrode Gryphon T and P BR Anchors GRYPHON Flex Knotless PEEK Anchor GRYPHON Flex Knotless Biocomposite Anchor Vapr Vue Generator, Vapr 3 Electrosurgical GLOBAL SHOULDER HEALIX ADVANCE SP PEEK Anchor GRYPHON Anchors with DYNACORD Suture Bioknotless Plus Lupine Loop Plus Anchor STRICKLAND ORTHOCORD SUTURE SUTURE DELTA XTEND Reverse Shoulder System PERIOSTEAL ELEVATOR GLOBAL ADVANTAGE FMS VUE system FMS Interface Cable Duo/Solo RapidLoc GLOBAL CAP RIDIDFIX Omnispan Meniscal Repair System Gryphon P BR Single and Double Arm Meniscal Needles AGILITY GLOBAL FX GLOBAL AP GLOBAL STEPTECH DELTA XTEND Reverse Shoulder System GLOBAL UNITE DELTA CTA Shoulder System BIOROC EZ SUTURE BONE FASTENER VAPR Electrode w/Integrated Handpiece RC GLOBAL ADVANTAGE GLOBAL STEPTECH GLOBAL CAP ARTHROSCOPE GLOBAL UNITE Platform Shoulder System Short Stem Mitek MILAGRO ADVANCE Screw OMNICUT Resection Blade Permaloop Suture Permatape Suture Milagro Advance PEEK AGILITY ORBITAL BOLT MULTIPLE WASHER NUT Fastin RC 2.3mm Side Effect Electrode FMS VUE Healix PEEK GLOBAL UNITE DELTA XTEND Reverse Shoulder System GLOBAL AP Femoral Intrafix System Electrode, Foot Pedal, Pump, Remote Control Versalok Pre-packed W/Orthocord Healix Advance Knotless PEEK Anchor RIGIDFIX Curve NEUFLEX DELTA XTEND Reverse Shoulder System GLOBAL CAP NEUFLEX DELTA XTEND Reverse Shoulder System GLOBAL UNITE GLOBAL ADVANTAGE GLOBAL AP CANNULATED CROSS PIN SCREW SYSTEM ELECTROSURGICAL SYSTEM HEALIX TI 3 SUTURE ANCHOR with DYNACORD HEALIX TI ANCHOR with DYNACORD HEALIX TI ANCHOR with DYNACORD AND NEEDLES Latarjet Panalok Loop Bristow Latarjet BIODHOC OVS1 Video System DePuy Mitek Instrument Panalok RC Dual Suture ACCLAIM GRYPHON X Anchor HEALIX TRANSTEND Anchor Camera Control System with Light Source and Light Guides Minilok QA+ ADHOC CLAW HEALIX ADVANCE PEEK ANCHOR Abs. Micro QA+ Healix Advance IDEAL Suture Shuttle, Suture Grasper, Knot Manipulator, Suture Leader Caddy FASTIN RC ANCHOR Gryphon GLOBAL APG Mini QA+ Minilok QA+ Healix BR Anchor, Healix PEEK Anchor, Healix Transtend and more. DELTA XTEND Reverse Shoulder System CuffTack HEALIX ADVANCE Anchor with PERMATAPE Suture MITEK DRILL GUIDE MULTIPLE GUIDES Gryphon Anchor w/ProKnot Technology PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM Orthocord TIGHT-N Tendon Docking Anchor HEALIX ADVANCE SP BIOCOMPOSITE Anchor Mini Anchor Mini Quick Anchor Plus DePuy Mitek Instrument GLOBAL SHOULDER Healix Advance Knotless PEEK Anchor Drill bit Arthroscopic Equipment Cart Truespan Shoulder instruments Gryphon T BR Milagro Interference Screws GLOBAL UNITE Spiralok IRRIGATION UROLOGICAL(MULTIPLE) MITEK DRILL FIXATION SCREW BONE(MULTIPLE BRANDS) Bioknotless Rapide Lupine Loop Rapide DEPTH GUAGE DELTA XTEND Reverse Shoulder System Light Adaptor ACL GRAFT KNIVES GRAFT KNIVES HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture HD Arthroscope Healix TransTend Anchors GLOBAL ADVANTAGE INTRAFIX Advance DELTA CTA Shoulder System DELTA XTEND Reverse Shoulder System Anchor ACCLAIM GLOBAL AP GLOBAL APG+ DELTA XTEND Reverse Shoulder System GLOBAL ADVANTAGE VAPR ARCTIC Suction Electrode Vapr "T" Electrode Mitek QuickAnchor INSERTER MITEK INSERTERS Healix Advance Anchors with Dyna+Tape Sutures RC/GII Super Anchor - Orthocord VAPR 2.3mm Wedge Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2026-03-27
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-10
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-11-22
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2011-11-22
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-07-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-04-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-04-12
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-16
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2012-01-16
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-01-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-16
HWA	Impactor	Orthopedic	Class 1	888.4540	2019-01-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2004-03-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2004-03-08
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2019-01-11
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-17
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-11-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-11-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-01-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2015-05-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-10-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-10-27
HTO	Reamer	Orthopedic	Class 1	888.4540	2004-03-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2004-03-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2004-03-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-06-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-01-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-01-17
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2019-01-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-06-14
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-08-21
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-11-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-01-08
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-01-08
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-07-31
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-03-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-03-26
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	1992-07-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2020-09-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-09-01
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-09-12
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-09-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2011-11-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2021-09-16
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2021-09-16
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2021-09-16
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2001-11-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2019-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-11-11
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2019-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-10
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-11-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-09-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-09-12
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-01-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-09-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-09-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-11-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-06-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-06-13
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-12-20
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-03-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-05-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-05-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-03-06
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-06-13
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-03-28
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-08-06
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2014-04-04
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2017-07-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2017-07-27
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2022-04-22
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2022-04-22
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2022-04-22
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2022-04-22
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2022-04-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2022-04-22
HRX	Arthroscope	Orthopedic	Class 2	888.1100	1997-04-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1997-04-14
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2017-07-27
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-03-14
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-03-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-03-14
HWJ	Awl	Orthopedic	Class 1	888.4540	2004-03-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-03-21
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2018-08-30
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2018-08-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-17
JEB	Table, Surgical With Orthopedic Accessories, Manual	General, Plastic Surgery	Class 1	878.4950	2019-01-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2006-03-07
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2006-03-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-10
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-03-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-11-08
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-07-08
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-17
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2011-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-01-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-01-17
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2012-01-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-01-17
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2004-03-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-11-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2001-11-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-03-28
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-11-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-11-25
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2020-11-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-02-06
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-02-06
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-07-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-06-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-07-08
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2019-01-11
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2002-02-08
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	1995-01-31
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2011-11-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-06-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-06-13
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-03-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-01-17
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-10
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2008-04-23
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2012-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2012-01-17
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-01-17
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2012-01-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-07-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2013-06-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-06-07
KYJ	Prosthesis, Finger, Constrained, Polymer	Orthopedic	Class 2	888.3230	2019-01-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2020-02-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2020-02-28
HTQ	Broach	Orthopedic	Class 1	888.4540	2019-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2004-03-08
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2004-03-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-11-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-03-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-04-11
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2004-02-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	1997-04-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	1997-04-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2002-04-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-17
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2019-01-11
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2019-01-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-03-18
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-03-18
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2017-11-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2003-09-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-06-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-03-14
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2004-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	1995-01-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	1995-01-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-06-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-06-25
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-01-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-17
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-10-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2015-10-16
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-10-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-10-16
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-12-09
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-12-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-16
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2017-06-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-06-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2004-03-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2014-07-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2014-07-10
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2004-03-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2004-03-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2004-03-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-06-07
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2013-06-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-08-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2019-11-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-17
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2004-03-08
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2019-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-05-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-07-11
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2008-12-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-04-26
HWK	Trephine	Orthopedic	Class 1	888.4540	2022-11-01
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-11-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-01-16
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2002-02-08
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2002-02-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2004-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2006-09-22
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2012-01-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-01-17
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2012-01-17
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2012-01-17
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2004-03-08
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-10
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2019-01-10
FSX	Light, Surgical, Connector	General, Plastic Surgery	Class 2	878.4580	2023-08-28
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2004-03-08
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2020-07-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-07-09
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-11-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-09-22
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2011-09-22
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2011-09-22
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2019-01-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-10-18
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2016-10-18
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-01-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-08-25
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2019-01-11
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Orthopedic	Class 2	888.3160	2019-01-11
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2019-01-11
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2019-01-11
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-01-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-08-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-06-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-07-27
GEF	Applier, Staple, Surgical,	General, Plastic Surgery	Class 1	878.4800	2004-03-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-07-09
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2019-07-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-22
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-11-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-06-13

Official Correspondent

Karen Parker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

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
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0023-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06	Zimmer Inc.	2	Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221934. Last updated year: 2026. Please use registration number 1221934 when referencing this establishment in official correspondence.