SYMMETRY MEDICAL, INC. - MANCHESTER

FDA Device Registration & Listing · MANCHESTER, NH, US · Registration 1221053

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1221053
FEI Number
1221053
Entity Name
SYMMETRY MEDICAL, INC. - MANCHESTER
City/State/Country
MANCHESTER, NH, US
Establishment Address
253 Abby Rd, MANCHESTER, NH 03103, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Tecomet (Owner Number: 1828464)
Owner / Operator Contact Address
170 New Boston Street, --, Woburn, MA 01801, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LimiFlex Instrument Tray AcuFex Graftmaster III (Tray Only) Signia Sterilization Tray Jones-FX Ultra System Integra TELIGEN Sonicision Reusable Sterlization Tray Ibis™ Pedicle Screw System KobyGard System Pkg, Matrix Mandible Upper Tray Screw Insert Rack 4.5 mm Cancellous Screws Self-Tapping Tray, Surgical Instrument COMPLETION MBT+PAT PRP TRY SET PINN CERAMIC INSERTER CASE QUICKSET SCREW CASE COMPLETE TRUMATCH TIB TRIAL TRAY SZ 8 TRUMATCH TRAY TIB 4 INCOMPASS Large Distractor Graphic Case Pkg, Matrix Midface Tray Trinica CORAIL EXPAN TRAY SIZES 15-20 PINN MODULAR RASP INST CASE RECLAIM RMR INDEX CARRIER14-21 TRUMATCH TRAY FEM 1.5 TRUMATCH TRAY TIB 5 Balanced Knee System High Flex Vitamin E PS Tibial Insert and Patella Harmony Pkg, Finger Mat Pkg, Matrix Mandible Instrument System Tray Screw Insert Rack 4 mm Cortical Screws Self Tapping Thoracolumbar Common ATTUNE REV SLD FB INSRT SZ9-10 ATUN REV RT FEM CTT SZ 3-8 CS QUICKSET ACE GRATER CS B TRAY TRUMATCH TIB TRIAL TRAY SZ 5 Large Universal Tray Lid MMFS Pkg, Multi-Clamp Insert Tray Universal Intrument Tray ATTUNE FEM SIZING & FINISH GLO ADV GLENOID CASE LID PINNACLE AB TRIAL CASE RECLAIM TAPERED RMR CASE 22-27 SOL 10IN L/R TRL TRAY COMPLETE BENGAL STK TRAY LID Forceps Insert Assembly, Matrix Rib Fixation System Insert Assembly Neuro BPS Tray Insert Pkg, Lid For Matrix Mandible Instuments Single Instrument Caddy 65g1098 Solan ATTUNE REV TIB AUG CADDY 7-8 KNEE BALANCER INST TRAY BLI TRUMATCH FEM TRIAL TRAY SZ 6 TRUMATCH TRAY FEM 3 FORTITUDE INSTRUMENTS Insert Assembly Neuro Instrument Tray Insert Pkg, Lid Mandible External Fixation System Small Instrument Tray Base Resorbable Fixation System ATTUNE REV TIBIAL BROACH CADDY MBT & LCS COMP INS TRL TRY LID TRUMATCH FEM TRIAL TRAY SZ 7 TRUMATCH TRAY FEM 4 CORAIL BROACH TRAY FULL RANGE Assembly Matrix Mandible Instrument System Insert BACFIX Case Assembly CR/CD Graphic Case GLO ADV GLENOID BOTTOM INSERT Module Assembly RFS Bending Template Pectus Bar Case Posterior Access Base ATTUNE REV FEM BROACH CADDY S-ROM*FEM INST MILL/CUT SH TRY 3.5 mm Implant Module, Base, Proximal Tibia Plate Assy, Matrix Mandible Caddy Den Tray Mini NEX-LINK OCTAFIX ATTUNE PS TRIALS SZ 3-5 PINNACLE SCREW SET CASE SP2*BAS FE INST ST TRY HD DOWN TISSUE SPARING FEM CORE BASE 1 DEROTATION TRAY Assy, Resorbable Cranial Clamp Extra Large Lid Neuro Fixation System Insert Assembly Cranial Clamp Tray Insert Pkg, Lid 2.7/3.5 Screw Rack Silhoette Thrclmbr Fx Ins ATTUNE REV TIB AUG CADDY 5-6 TRUMATCH FEM TRIAL TRAY SZ 5 TRUMATCH TRAY FEM 2.5 Assy, Block Matrix Mandible Instrument System Lid Matrix Neuro Flat & Preformed Mesh Neuro Fixation System, Base, Lid & Mat Vusion® OS ATTUNE MI TRAY PINNACLE BEARING REMOVAL CASE RECLAIM TPD RMR 28-31 DIA CASE SOL 8IN STRAIGHT TRL TRAY COMP BENGAL STK XLG IMP CADDY Assy, Matrix Rib Fixation System Encompass® Cemented Hip System Ortho Development™ Balanced Knee System Pkg, Flap Fix Plate ATTUNE REV DISASSEMBLY CASE ATTUNE REV SLD RP INSRT SZ7-8 SP2FEM NCHGD BOXTRLS SIGINSRT TISSUE SPARING FEM CORE LID 2 Assy, Matrix Orthognathic Insert Tray DTO® 5.5 UTS Ophthalmic Instrument Tray Xomed Insert Tray, Large Benders Matrix Mandible System Pkg, Matrix Combination Midface Tray SPEEDLINK ACTIS BROACH CASE BASE ATTUNE RP PS TRL TRAY 2 MBT REV PREP STER TRAY REV REAMERS STER TRAY TRUMATCH TRAY FEM 6 Pkg, Finger Mat, Half Size Nano Inst. Module ATTUNE REV ASSEMBLY CASE ATTUNE REV SLD RP INSRT SZ5-6 SP2*TC3 INS TRLS ST TRAY INS TISSUE SPARING FEM CORE LID 1 7x11 Dbl Lvl W/ Logo, R1067 Solan Base Assy, Matrix Rib Fixation System Integra R-9105 Fukushima-day Maxillary Footplate Insert, External Midface Distractor ATTUNE CR TRIALS SZ 3-8 OFSET TIB CEM PNCH STR TRY INS SIG HP REV FEMORAL PREP CASE TRUMATCH TRAY TIB 2 EXP DEROTATION SCREW EXT TRAY Balanced Knee System High Flex PS Graphic Case ADRF Set Pkg, Bps Insert Tray Pkg, Matrix Mandible Instrument System Scope Tray ATTUNE REV SLD FB INSRT SZ3-4 ATTUNE TIB PREP POR & IMPACT QUICKSET ACE GRATER CASE LID TC3 RP INSERT TRIAL STER TRAY TRUMATCH TIB TRIAL TRAY SZ 4 Balanced Knee System Modular Revision Knee System HARMONY Interchangeable Lid, Assembly, 3.5 mm Proximal Tibia Plate Pkg, Finger Mat, Full Size Nano Inst. Module Pkg, Matrix Mandible Lower Tray Screw Insert Rack 4.35 mm Cancellous Screws Self-Tapping Trauma One Tray ATUN REV TIB AUG CADDY 9-10 QUICKSET ACE GRATER CS COMPL TRUMATCH TIB TRIAL TRAY SZ 6 Insert Tray Assembly Matrix Neuro Instruments Pkg, Lid, Mandible External Fixation System Phase Small Instrument Tray Lid Resorbable Fixation System ATTUNE REV TIP RP & BROCH CASE MBT & SIGMA RP INS TRL TRY LID RECLAIM TPD RMR CASE 18-27X290 TRUMATCH FEM TRIAL TRAY SZ 8 TRUMATCH TRAY FEM 5 3x7 W/logo Blue Mat Xomed, R1063 Instrument Insert Tray Assembly Resorbable Fixation System Matrix Neuro System Case Base Surgical Instrument Tray ATT TIB PREP PLUS-IMPACT MBT TIB PREP STERIL TRAY LID RP STAB TRLS 20-25MM STER LID TRUMATCH TRAY LID CONNECTION TRAY Assy, Preformed Reconstruction Disk, Base and Lid Escalade Acetabular Cup System INFIX Ovation® Hip Stem Pkg, Lid 2.7/3 5/4 Screw Rack SILHOETTE Thrclmbr Fx Ins ATTUNE REV TIB AUG CADDY 3-4 TRUMATCH FEM TRIAL TRAY SZ 4 3.5 mm Implant Module, Assembly, Proximal Tibia Plate Assy, Insert Tray, Matrix Neuro Instrument Tray W/ Bpd Common M3-X System NEX-LINK OCTA FIX ATTUNE PRIMARY RESECTIONS PINNACLE REV SHELL TRIAL CASE SP2 KEELPNCH STERTRAY INSRT EXP 55 DEROTATION REDUCTION TR Assy Lid, Matrix Mid Face Tray Block BAK Instruments Case Assembly Matrix Rib Fixation System GLO ADV GLENOID MIDDLE INSERT PHANTOM CS STERILIZATION TRAY-INSERT Reamer Tray Assembly Flexible Humeral Nails ATTUNE REV FEM BROACHING CASE S-ROM*FEM INST/SZ16-24 TRY TRUMATCH PREP TRIAL INSTR TRAY 7x11 Shallow W/custom Mat & Sil Str Solan Base Extra Large Tray Neuro Fixation System Medium Distractor Graphic Case ATTUNE FB CR TIB INS CORE TRLS OFSET TIB NCEM PNCH STR TRY IN SIG HP REV FEMORAL TRIAL CASE SP2POR MOD PUNCH STERIL TRYINS TRUMATCH TRAY TIB 2.5 EXP DEROT SCRWEXT TRAY-MDIFIED BAK LUMBAR IBF Instrument ceramys® GLO ADV GLENOID TOP INSERT Pivot™ Bipolar Head ReFlexion System ATTUNE REV GEN FEM PREP CASE ATTUNE SHIMS & GEN INST S-ROM/UNI-ROM FEM INST STARTER TRUMATCH PRIM RES INSTR TRAY ACUFIX Base Large Tray Neuro Fixation System Mergence ATTUNE FB CR TRL TRAY 2 ATTUNE REV FEM AUG CADDY 1-2 PINN AB INSERTER CASE COMPLETE SIG HP REV TC3 RP INSRT/SP BLK S-ROM FEMORAL INST DDH KIT BAK Lumbar IBF Instrument CERVICAL COMMON INSTR GLOBAL ANCHOR PEG GLENOID CASE Pkg, Black Silicone Finger Mat Pkg, Matrix Mandible Instrument Lid Reusable Instrument Tray ATTUNE REV GEN TIB PREP CASE ATTUNE STEMMABLE FB TIB PREP S-ROM/UNI-ROM FEM INST TRL SZ TRUMATCH TIB TRIAL TRAY SZ 3 ACUFIX THINLINE SPECIFIC INSTR Caddy MINCRO System Pagoda™ Pedicle Screw System ATTUNE FB CR TRL TRAY 3 ATTUNE REV FEM AUG CADDY 3-4 SIGMA INSET PAT TRL&INST TRAY S-ROM MI BROACH CASE CMPLT Assy, Oba Combo Set Enovis Cones Tray Ovation Tribute Hip Stem; Ovation Narrow Hip Stem Pkg, Insert Rfs Finger Mat Tray Set Tray ATTUNE REV FE GUIDE PREP CASE ATTUNE REV STEM TRIALS CASE TRUMATCH FEM TRIAL TRAY SZ 3 Assy, Matrix Neuro Add-On Tray DTO 5.5 UTS OCTAFIX ATTUNE PS TRIALS SZ 6-8 ATTUNE REV SLD RP INSRT SZ3-4 QUICKSET ACE GRATER CASE BASE SP2*GEN INSERT INST ST TY INS TISSUE SPARING FEM CORE BASE 2 Balanced Knee System Ultracongruent Tibial Insert Hemi System ISS Integrated Spine Pkg, Matrix Mandible Preformed Reconstruction Plates Tray Lid Screw Insert Rack 4.5 mm Cancellous Screws Self-Drilling TRAXIS TI CEMENTLESS IMPACTION QUICKSET ACE GRATER CS M TRAY TRUMATCH TIB TRIAL TRAY SZ 7 TRUMATCH TRAY TIB 3 Assy, External Mid-Face Distractor M3M4 System NEX-LINK Vusion™ PEEK VBR System ATTUNE PATELLA PREP GEN 2 PINNACLE LG POLY TRIAL CASE SP2 CEM MOD PNCH STERL TRY INS BENGAL STK DIST FT/AWL CADDY Alpine Hip Stem Assy, Screw Block Cadence MMFS Standard Screwdriver Tray Insert Pathfinder ATTUNE FB PS TIB INS CORE TRLS ATTUNE REV FEM AUG CADDY 5-6 SIGMARP CVD/PS INSTRL TRAY LID SROM* CASE PATELLA INST ASS'Y Assembly Battery Powered Screwdriver Assy, Screw Module Matrix Rib Fixation System CADENCE MMFS Trocar Tray - B PATHFINDER Pkg, Silicone Finger Mat ATTUNE FB PS TRL TRAY 2 ATTUNE REV FEM AUG CADDY 7-8 S-ROM*FEM EXTRACTOR INSTR TRAY 4.5 mm Implant Module, Assembly, Proximal Tibia Plate Instrument System Tray Matrix Neuro System Instrument Tray System Tray ATTUNE BAL BLK TRAY MBT WEDGE TRIALS STER TRAY RP STAB TRLS 20-25MM STER TRAY TRUMATCH TRAY TIB 1.5 DEROTATION/CONNECTION CASE & L Lid Assy, Matrix Rib Fixation System Multi-Purpose Tray Pkg, Quarter Mandible Plating System Lid Vusion® CS Plus ATTUNE INST SZ 1-2 PINNACLE BANTAM CASE RECLAIM TAPRD RMR INDEX 14-21 SOL 8IN L/R TRL TRAY COMPLETE BENG STACK STD 3 LEVEL IMP CDY Large Instrument Tray Base Resorbable Fixation System Pkg, Matrix Orthognathic Instrument Tray Trinica Cervical Instr GLO ADV GLENOID CASE & INSERTS PINN REV XL GRATER/TRIAL CASE RECLAIM TAPERED RMR CASE 14-21 SMARTSET*UNIV STR REAM ST TRAY TRUMATCH TRAY FEM 2 TRUMATCH TRAY TIB 6 Instrument Insert Assembly Matrix Rib Fixation System ManFrac MFx System Pkg, Matrix Combo Mandible Tray Sterilization Tray ACTIS CORE CASE BASE MBT RP/PS TIB INSTRL STER TRAY REV STEM TRIALS STER TRAY TRUMATCH TRAY FEM PAT Ultra System Sterilization Tray Silicone Mats Superpath Basket Reamer 40mm Hex Offset Reamer Driver Patella Preparation Acetabular Reamer MBT Central Drill Instrument, Surgical, Orthopedic, AC-Powered Motor and Accessory/Attachment MULTIPAK METAPAK PROXISURE Sterilization Tray Container Instrument Container IMP Sterilization Case for De Mayo Knee Positioner, 706 (S, L, XL) Implant Container Kit Container Tray Symmetry Surgical Quad-Lock Sterilization Container System ROSA® KNEE INST CASE ROSA® KNEE TRAY Ultra System Karl Storz Radel Sterilization Trays Intuitive Surgical Instrument and Accessory Sterilization Trays ST360 Degre Thraclmbr Fix Inst FEM PLNR PILOT MOST NEXGEN 5-IN-1 FEM CUT GDE DJO Surgical MIKA Knee Guide I-Hip TIBIAL CUT GUIDE, SWIVEL HEAD SPOUT MILL GUIDE BODY EXT ROT CUT GDE, LT MED/RT LAT 7 DEG CUT GUIDE NEXGEN AP CUT GDE TIBIAL IM ALIGNMENT GUIDE NK POLY PATELLA DRILL GUI BIOMET GUIDE, SURGICAL INSTRUMENT DARCO BIOMET SURGICAL GUIDE DJO Surgical Head Gage Plate Recon 3.2mm Guide Wire Sleeve General Instruments Recon Drill Sleeve Recon Interlock 4.3mm Drill Sleeve guide, surgical, instrument TURON, GLENOID SIZING GUIDE Cut- Guide, Em Tibial MI Mika MI Tibia Cut Guide DISTAL RE-CUT GUIDE Compress Instruments Long Reduction Tool Guide, 2 Degree VAR/VAL MI Carpal Tunnel Release Instruments Guide FEMORAL CUTTING GUIDE CNVSN GD NK CONSTR PRI TIBIAL SIZER 3 DEG CUT GUIDE Guide, Surgical Inst NEXGEN STEM TIB DR GDE PRI FEM SIZING GD MOST TIB RMR GD MOST DJO Surgical MIKA Cut Guide EXT ROT CUT GDE, RT MED/LT LAT REV DST FEM SAW GD 60 C Guide, surgical, instrument - Orthopedic manual surgical instrument DISTAL FEMORAL SAW GUIDE 0 DEG CUT GUIDE Guide Drill APR FEMORAL OSTEOTOMY GUI PRI DSTL FEM SAW GD MOST CUSA Clarity Ultrasonic Surgical Aspirator System CUSA Clarity Ultrasonic Surgical Aspirator System Tray, Surgical Instrument Tray, surgical, instrument - manual surgical isntrument for general use. DJO Surgical Tray Bracket DJO Surgical Quick Launch Case 4MM Guided Surgical tray 4.5MM Guided Surgical tray 5MM Guided Surgical Tray Instrument Case MULTIPLE-SCOPEPAK CUSTOMEPAK MICROPAK MBT TRAY TRIAL FIXATION PINS Tray Lap Chole Holds 2 Scopes and 12 Instruments Arthroscopy and ENT Instrument Tray Brackets, Universal Scope Protector Extra Long Tray, Plastic Operative Scope Tray Flexible Fiberscope Tray, 1 Tier with Accessory Box 10MM Dual Endoscopes Tray Flexible 7325 Series Scope Tray Long Single Scope Tray Single Scope 1.9, 2.7, and 4mm Rigid Tray Compact Scope and Mini Compact Scope Tray 2.7mm Office Hysteroscope Tray 4MM Dual Scope, ENT or Arthro Tray Camera Head and Cord Tray Viper Flexible Ureteroscope Tray 4MM Dual Scope Hysteroscope and Cysto Tray TELIGEN Screw and Plate System Instrumentation Myosure Instrument Tray Cervical Allograft Instrument Tray Cervical Titanium Spacer System Instrument Tray Sierra Hermosa ACDF UL-PKTRAY ACE Sinus Lift Osteotomes (Tray Only) ACE Offset Osteotome (Tray Only) ACE Implant Dilators (Tray Only) Restore Implant System (Tray Only) Prima Implant System (Tray Only) XP1 Implant System (Tray Only) Stage-1 Implant System and Renova Implant System (Tray Only) ACE Ridge Expanding Chisel Osteotome (Tray Only) ACE Sinus Lift (Tray Only) ACE Bone Screw Tacking Kit (Tray Only) Genesis Implant System (Tray Only) ACE Paralleling Drill Guide (Tray Only) MULTIPAK METAPAK MULTIPLE-FLASHPAK LOW PROFILE TIBIA TARGET ARM Integra surgical instrument LOW PROFILE TIBIAL JIG TAPER CEM STEM TRIAL Corail AMT Neck Seg RECLAIM PROX TRIAL SHAFT GROOVED SMALL TAPER 32mm + 5 TRIAL HEAD Template ARTIC/EZE TR BALL GRVD PINN AB IN TR OFFSET TIB TRAY TRIAL PINNACLE TRIAL SHELL Trumatch Fixed Post Reference Guide SP2 MI FEM NOTCH GD Sig Fem Adp Slv Blt Trl Neutral Attune S-ROM Stem System LCS PAT RESECT GDE 60 SAWBLADE Max 4 Size Patella Template Quickset Screw System Biomet Template Zimmer Patellofemoral joint prosthesis (PFJ) Instrumentation Modular Endo Heads EXTENDED TIBIA JIG SPRING Sigma STROM Oblong Cup - Alignment Guide CHARLOTTE SP*2 ROD,REAMER,SLEE STER TRAY SP2PLI/CVD TIBINS TRL STERTRY CUSA Excel Ultrasonic Surgical Aspirator System LapCare/Arthrocare Opitainer Modultainer II Instrument Cassettes Modultainer II Hybrid Vault Modultainer III Universal Modultainer IV Minitainer Standard Modultainer Vertebral Preparation System (Tray Only) Integra Hip System Instruments Echelon Emperion Symergy Modultainer III Universal Minitainer Vault Instrument Cassettes Modultainer IV Standard Modultainer LapCare/Arthrocare Opitainer Modultainer II Modultainer II Hybrid Parrell Wire Guide Biomet Cannulated Screw System Omni Instrument Tray Zimmer Trabecular Metal Total Ankle TRAY, UDEL, FLEXIBLE CMOS VIDEOSCOPES TRAY, UDEL, 2 RIGID SCOPES 4MM X 18CM TRAY, UDEL, INLINE CAMERA HEADS TRAY, UDEL, PENDULUM/INLINE CAM HEADS TRAY, UDEL, STANDARD CAMERA HEADS TRAY, UDEL, RIGID 10MMX33CM SCOPE/CABLE TRAY, UDEL, 2 RIGID SCOPES/CABLE TRAY, UDEL, 2 RIGID SCOPES 5.5MM X 33CM TRAY, UDEL 2 RIGID SCOPES 10MM X 33CM TRAY, UDEL, 1 RIGID SCOPE 4MM X 30CM TRAY, UDEL, FLEXIBLE FIBERSCOPE TRAY, UDEL, 2 RIGID SCOPES 5.5MM X 53CM TRAY, UDEL, 2 RIGID SCOPES 4MM X 30CM TRAY, UDEL, FLEXIBLE CCD VIDEOSCOPES TRAY, UDEL, INLINE/C-MOUNT CAMERA HEADS TRAY, UDEL, 1 RIGID SCOPE 10MM X 33CM TRAY, UDEL, FLEXIBLE FIBERSCOPES TRAY, UDEL, 4 RIGID SCOPES/CABLE Karl Storz Udel Sterilization Trays

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 2012-12-12
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2025-09-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2009-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-01-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2018-09-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-08-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2009-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-01-11
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2005-03-14
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2007-02-22
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2001-05-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-11-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-11-14
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2009-10-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2022-06-06
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2012-12-07
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2001-05-10
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-09-24
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2025-09-24
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-09-24
LBK Neurosurgical Ultrasonic Instruments Unknown Class U N/A 2025-09-24
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-08-05
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2012-11-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-22
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-22
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2013-02-22
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-03-28
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-01-15
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2013-01-15
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-01-09
OFY Dental Implant Surgical Tray Dental Class 1 872.3980 2013-01-15
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2007-02-22
HWT Template Orthopedic Class 1 888.4800 2013-01-29
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2025-09-24
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2012-03-16
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-01-09
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-01-06
JDJ Mesh, Surgical, Acetabular, Hip, Prosthesis General, Plastic Surgery Class 2 878.3300 2014-01-06
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-01-06
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-01-06
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2014-01-06
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-01-06
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-01-06
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2014-01-06
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2014-01-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-01-06
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2014-01-06
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2014-01-06
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2014-01-06
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2012-03-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-23
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2019-04-29
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2019-02-06
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tecomet
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1225675 Tecomet Inc. Wilmington, MA, US
3003791208 SYMMETRY MEDICAL MANUFACTURING INC. Lansing, MI, US
3005226664 Tecomet, Inc. Wilmington, MA, US
3004196040 SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD SHEFFIELD, SOUTH YORKSHIRE Barnsley, GB
1226425 TECOMET Woburn, MA, US

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-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0332-2022 Covidien Llc U
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221053. Last updated year: 2026. Please use registration number 1221053 when referencing this establishment in official correspondence.
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