Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001239363

FEI Number

3001239363

Entity Name

3D MEDICAL MANUFACTURING, INC. (dba Tecomet)

City/State/Country

Riviera Beach, FL, US

Establishment Address

1006 West 15th Street, Riviera Beach, FL 33404, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

3D Medical Manufacturing, inc. DBA Tecomet (Owner Number: 10043250)

Owner / Operator Contact Address

2001 Congress Avenue, Riviera Beach, FL 33404, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PLATE, FIXATION, BONE APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis APPLIANCE, FIXATION, SPINAL INTERLAMINALAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL DILATOR, CANNULATED UNIVERSAL REPLACEMENT, OSSICULAR PROSTHESIS, TOTALPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis JET-X DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS DISTAL CLAVICLE PLATE, SHORT, LEFT, SS DISTAL CLAVICLE PLATE, SHORT, RIGHT, SS LO-PRO LOCK SCRW,SS 3.5X 8MM DISTAL CLAVICLE PLATE, 8 HOLE, RIGHT, SS APPLIANCE, FIXATION, SPINAL INTERLAMINAL EXTRAMEDULLARY ALIGNMENT ROD LOW PROFILE SCREW, TI, 4MM X 10MM LOW PROFILE SCREW, TI, 4MM X 12MM 2.4 X 38MM VAL SCREW, Ti 2.4 X 36MM VAL SCREW, Ti 2.4 X 40MM VAL SCREW, Ti LOW PROFILE LOCKING SCREW, 2.4 X 20MM LOW PROFILE SCREW, TI, 4MM X 48MM LOW PROFILE LOCKING SCREW, 2.4 X 26MM LOW PROFILE LOCKING SCREW, 2.4 X 16MM LOW PROFILE LOCKING SCREW, 2.4 X 36MM LO-PRO SCRW,TI,3.5MMX 50MM LOW PROFILE LAPIDUS PLATE, TITANIUM LOW PROFILE LOCKING SCREW, 2.4 X 34MM LOW PROFILE LOCKING SCREW, 2.4 X 24MM LOW PROFILE LOCKING SCREW, 2.4 X 32MM LO-PRO SCRW,3.5X 54MM LO-PRO LOCK SCRW,3MMX 40MMTI LOW PROFILE LOCKING SCREW, 2.4 X 30MM LO-PRO SCRW,TI,3.5MMX 48MM LO-PRO LOCK SCRW,3MMX 26MMTI LO-PRO SCRW,TI,3.5MMX 60MM LOW PROFILE SCREW, 4 X 52MM LOW PROFILE LOCKING SCREW, 2.4 X 14MM LO-PRO LOCK SCRW,3MMX 30MMTI LO-PRO MTP PLT,CONTRD,STD,R,TI LO-PRO SCRW,3.5X 56MM LOW PROFILE SCREW, 4 X 56MM LOW PROFILE LOCKING SCREW, 2.4 X 8MM LO-PRO LOCK SCRW,3MMX 28MMTI LOW PROFILE LOCKING SCREW, 2.4 X 40MM LOW PROFILE SCREW, TI, 4MM X 46MM LOW PROFILE SCREW, 4 X 58MM LOW PROFILE LOCKING SCREW, 2.4 X 22MM LO-PRO MTP PLT,CONTRD,STD,L,TI LOW PROFILE SCREW, TI, 4MM X 60MM LO-PRO LOCK SCRW,3MMX 32MMTI LO-PRO SCRW,TI,3.5MMX 46MM LOW PROFILE LOCKING SCREW, 2.4 X 12MM LO-PRO SCRW,3.5X 52MM LOW PROFILE LOCKING SCREW, 2.4 X 18MM LOW PROFILE LOCKING SCREW, 2.4 X 38MM LOW PROFILE LOCKING SCREW, 2.4 X 28MM LOW PROFILE SCREW, TI, 4MM X 50MM LOW PROFILE SCREW, 4 X 54MM LOW PROFILE LOCKING SCREW, 2.4 X 10MM LO-PRO LOCK SCRW,3MMX 34MMTI LO-PRO LOCK SCRW,3MMX 38MMTI LO-PRO SCRW,3.5X 58MM LO-PRO LOCK SCRW,3MMX 36MMTI Guide, surgical, instrument PLATE, FIXATION, BONEScrew, fixation, bone SCREWDRIVER 2.4 X 20MM VAL SCREW, Ti 2.4 X 8MM VAL SCREW, Ti 2.4 X 30MM VAL SCREW, Ti 2.4 X 26MM VAL SCREW, Ti 2.4 X 16MM VAL SCREW, Ti 2.4 X 34MM VAL SCREW, Ti 2.4 X 28MM VAL SCREW, Ti 2.4 X 18MM VAL SCREW, Ti 2.4 X 22MM VAL SCREW, Ti 2.4 X 14MM VAL SCREW, Ti 2.4 X 24MM VAL SCREW, Ti 2.4 X 12MM VAL SCREW, Ti 2.4 X 32MM VAL SCREW, Ti 2.4 X 10MM VAL SCREW, Ti SYNTHES 1/1.2 MM PLUSDRIVE SCREWS LOW PROFILE LOCKING SCREW, 3.5 X 54MM LOW PROFILE LOCKING SCREW, 3.5 X 52MM LO-PRO LOCK SCRW,TI,3.5MMX 12MM LO-PRO LOCK SCRW,TI,3.5MMX 10MM LOW PROFILE LOCKING SCREW, 3.5 X 56MM LOW PROFILE LOCKING SCREW, 3.5 X 58MM LO-PRO LOCK SCRW,TI,3.5MMX 50MM LO-PRO LOCK SCRW,TI,3.5MMX 48MM LO-PRO LOCK SCRW,TI,3.5MMX 46MM LO-PRO LOCK SCRW,TI,3.5MMX 60MM DRILL, SURGICAL, ENT APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Screw, fixation, bone 4.5/5.7MM LOCKING SCREW GUID 4.5MM LCK DRILL GUIDE INSRT 3.5MM LOCKING SCREW GUIDE 2MM LCK DRILL GUIDE INSERT 2MM K-WIRE LCK GUIDE INSRT APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis, spondylolisthesis spinal fixation SEMIEXTENDED GUIDE BOLT CANNULATED IMPACTOR - LONG 7/16 GUIDE BOLT LONG HEXDRIVER Vitality Transverse Connector Assembly Fixed Vitality Transverse Connector Assembly Adjustable Vitality Closure Top Shear Off Vitality Top Loading Polyaxial Screw Assy Vitality Closure Top Torque Limit LO-PRO SCRW TM SS 2.7MMX 10MMCORTEX LO-PRO SCRW TM SS 2.7X 40MMCORTEX LOW PRO SCRW,TI,6.7X 90MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 110MM LO-PRO SCRW TM SS 2.7X 36MMCORTEX LOW PRO SCRW,TI,6.7X 60MMCANN,18MM THD LO-PRO SCRW TM SS 2.7X 46MMCORTEX LO-PRO SCRW,TI,6.7X 100MM LO-PRO SCRW TM SS 2.7X 58MMCORTEX LO-PRO SCRW TM SS 2.7X 20MMCORTEX LOW PRO SCRW,TI,6.7X 105MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 55MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 40MM LO-PRO SCRW TM SS 2.7X 34MMCORTEX LO-PRO SCRW TM SS 2.7X 48MMCORTEX LO-PRO SCRW TM SS 2.7X 42MMCORTEX LO-PRO SCRW TM SS 2.7X 18MMCORTEX LOW PRO SCRW,TI,6.7X 100MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 60MM LOW PRO SCRW,TI,6.7X 40MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 80MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 65MMCANN,18MM THD LO-PRO SCRW TM SS 2.7X 54MMCORTEX LO-PRO SCRW TM SS 2.7X 14MMCORTEX LO-PRO SCRW TM SS 2.7X 24MMCORTEX LOW PRO SCRW,TI,6.7X 75MMCANN,18MM THD LO-PRO SCRW TM SS 2.7X 28MMCORTEX LO-PRO SCRW TM SS 2.7X 44MMCORTEX LOW PRO SCRW,TI,6.7X 45MM LO-PRO SCRW T,SS 2.7X 60MMCORTEX LO-PRO SCRW TM SS 2.7X 56MMCORTEX LO-PRO SCRW TM SS 2.7X 52MMCORTEX LO-PRO SCRW TM SS 2.7X 16MMCORTEX LO-PRO SCRW TM SS 2.7X 22MMCORTEX LO-PRO SCRW TM SS 2.7X 50MMCORTEX LO-PRO SCRW TM SS 2.7X 30MMCORTEX LOW PRO SCRW,TI,6.7X 75MM LO-PRO SCRW TM SS 2.7X 38MMCORTEX LOW PRO SCRW,TI,6.7X 50MM LOW PRO SCRW,TI,6.7X 115MM LOW PRO SCRW,TI,6.7X 80MM LOW PRO SCRW,TI,6.7X 95MM LO-PRO SCRW TM SS 2.7X 32MMCORTEX LOW PRO SCRW,TI,6.7X 45MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 85MM LOW PRO SCRW,TI,6.7X 85MMCANN,18MM THD LOW PRO SCRW,TI,4.5X 60MMCANN PT THD LOW PRO SCRW,TI,6.7X 70MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 120MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 120MM LOW PRO SCRW,TI,6.7X 105MM LO-PRO SCRW TM SS 2.7X 26MMCORTEX LOW PRO SCRW,TI,6.7X 95MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 65MM LOW PRO SCRW,TI,6.7X 50MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 115MMCANN,18MM THD LOW PRO SCRW,TI,6.7X 55MM LOW PRO SCRW,TI,6.7X 90MM LOW PRO SCRW,TI,6.7X 70MM LO-PRO SCRW TM SS 2.7X 12MMCORTEX LOW PRO SCRW,TI,6.7X 110MMCANN,18MM THD MOTOR, DRILL, PNEUMATIC WASHER, BOLT NUTScrew, fixation, bone Alps Hand Instruments APPLIANCE, FIXATION, SPINAL INTERLAMINALAPPLIANCE BIT, SURGICAL HEX-FIX CANNULATED DRILL BIT FOR MINI TIGHTROPE CANNULATED DRILL BIT, 3.5 MM 2 MM DRV SFT FOR QCKFIX SCRW SYS IBALANCE TKA, IM DRILL JET-X TAP, BONE Orthopedic stereotaxic instrument MOTOR, DRILL, ELECTRICDRILLS, BURRS, TREPHINES & ACCESSORIES APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYORTHOSIS, SPINAL PEDICLE FIXATION MEDIAL PORTAL, MARKING HOOK ARM, 9MM MEDIAL PORTAL, MARKING HOOK ARM, 8MM MEDIAL PORTAL, MARKING HOOK ARM, 6MM T-FIX TUNL HK FOR MEDAL-PORT,11MM GUIDE SLEEVE, 3MM TRANSFIX II GUIDE PIN, 2.4MM ZEBRA BONE-TENDON-BONE GRAFT INSERTER MEDIAL PORTAL, MARKING HOOK ARM, 7MM MEDIAL PORTAL, MARKING HOOK ARM, 10MM 3 DRIVE SHFT FOR QUICKFIX SCREW SYSTEM IBALANCE TKA, UNIVERSAL IMPACTOR HANDLE CONSTANT PCL GUIDE DRILL SLEEVE, 3.5MM IBAL TKA,EM ALIGNMNT GD WO SPIKE CANNULATED COUNTERSINK, 6.7MM CANNULATED COUNTERSINK, 4.5MM APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis Valeo Pedicle Screw System Title 2 (Polyaxial Spinal System) SYNTHES 1MM TI. CORTEX SELF-DRILLING SCREWS (HAND & NEURO) APPLIANCE, FIXATION, SPINAL INTERLAMINALOrthosis, spondylolisthesis spinal fixationORTHOSIS, SPINAL PEDICLE FIXATION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-07-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-07-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-07-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-07-02
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2019-09-16
ETA	Replacement, Ossicular Prosthesis, Total	Ear, Nose, Throat	Class 2	874.3495	2013-07-02
ETB	Prosthesis, Partial Ossicular Replacement	Ear, Nose, Throat	Class 2	874.3450	2013-07-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-19
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2024-04-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-19
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3520	2020-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-16
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-07-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-02
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-07-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-04-10
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-16
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2013-07-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-11-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-06-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-07-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-07-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-06-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-09-16
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2019-09-16
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-09-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-09-16
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-09-16
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2019-09-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-16
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2013-07-02
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2013-07-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-02
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2021-12-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-07-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-07-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-07-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-07-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-07-02
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2017-04-10
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2024-04-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2019-09-16
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2024-04-30
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2013-07-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-07-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2013-07-02
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2013-07-02
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2013-07-02
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2013-07-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-07-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-07-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-09-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-01-04
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-01-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-01-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-12-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-04-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-07-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-07-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-07-02

Official Correspondent

Vanesa Fields

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

3D Medical Manufacturing, inc. DBA Tecomet

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
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001239363. Last updated year: 2026. Please use registration number 3001239363 when referencing this establishment in official correspondence.