Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616944

FEI Number

3003414678

Entity Name

SYNTEC SCIENTIFIC CORP.

City/State/Country

CHANG HUA Changhua, TW

Establishment Address

2, KUNG SAN ROAD, CHUAN SHING, INDUSTRIAL ZONE, SHEN KANG, CHANG HUA Changhua 509, TW

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Syntec Scientific Corporation (Owner Number: 9034982)

Owner / Operator Contact Address

No.2, Kung San Rd., Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, TW-CHA 509, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PERI LOCKING SCREW 3.5MM X 90MM, STERILE PERI LOCKING SCREW 3.5MM X 40MM, STERILE PERI LOCKING SCREW 3.5MM X 65MM, STERILE PERI LOCKING SCREW 3.5MM X 38MM, STERILE PERI LOCKING SCREW 3.5MM X 34MM, STERILE PERI LOCKING SCREW 3.5MM X 80MM, STERILE PERI LOCKING SCREW 3.5MM X 46MM, STERILE PERI LOCKING SCREW 3.5MM X 42MM, STERILE PERI LOCKING SCREW 3.5MM X 56MM, STERILE PERI LOCKING SCREW 3.5MM X 30MM, STERILE PERI LOCKING SCREW 3.5MM X 54MM, STERILE PERI LOCKING SCREW 3.5MM X 85MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 50MM, STERILE PERI LOCKING SCREW 3.5MM X 36MM, STERILE PERI LOCKING SCREW 3.5MM X 60MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 40MM, STERILE PERI LOCKING SCREW 3.5MM X 50MM, STERILE PERI LOCKING SCREW 3.5MM X 32MM, STERILE PERI LOCKING SCREW 3.5MM X 48MM, STERILE PERI LOCKING SCREW 3.5MM X 58MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 30MM, STERILE PERI LOCKING SCREW 3.5MM X 70MM, STERILE PERI LOCKING SCREW 3.5MM X 44MM, STERILE PERI LOCKING SCREW 3.5MM X 75MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 65MM, STERILE PERI LOCKING SCREW 3.5MM X 28MM, STERILE PERI LOCKING SCREW 3.5MM X 52MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 55MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 60MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 70MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 45MM, STERILE PERI CANNULATED LOCKING SCREW 3.5MM X 35MM, STERILE 3.5 CLOVERLEAF PLT,4 HOLE 4.5 SPOON PLT, 5 HOLE 3.5 CLOVERLEAF PLT,5 HOLE 2.7 MULTI-FRAGMENT PLT 4.5 SPOON PLT, 6 HOLE 3.5 CLOVERLEAF PLT, 3 HOLE 3.5 CLOVERLEAF PLT,8 HOLE 3.5 CLOVERLEAF PLT, 10 HOLE 3.5 CLOVERLEAF PLT,7 HOLE 3.5 CLOVERLEAF PLT,6 HOLE 4.5 COBRA HEAD PLT, 8HL X 170MM 2.7 T-PLT 4.5 L-BUTTRESS PLT, 4 HL LEFT 3.5 T-PLT, 4HL-HEAD 7HL-SHAFT QUARTER TUBULAR PLT, 3 HOLE 4.5 COBRA HEAD PLT, 9HL X 186MM QUARTER TUBULAR PLT, 7 HOLE 4.5 T-PLT, 5 HOLE ONE-THIRD TUBULAR PLT,12 HOLE QUARTER TUBULAR PLT, 6 HOLE SEMI-TUBLAR PLT, 9 HOLE 4.5 COBRA HEAD PLT, 11HLX218MM 3.5 T-PLT, 3HL-HEAD 5HL-SHAFT 4.5 T-PLT, 8 HOLE QUARTER TUBULAR PLT, 5 HOLE QUARTER TUBULAR PLT, 8 HOLE 4.5 T-BUTTRESS PLT, 6 HOLE 3.5 T-PLT,0BL,3HL-HD 5HL-SHAFT 4.5 T-PLT, 4 HOLE 4.5 T-BUTTRESS PLT, 5 HOLE ONE-THIRD TUBULAR PLT,10 HOLE 4.5 T-BUTTRESS PLT, 4 HOLE 4.5 L-BUTTRESS PLT, 4 HL RIGHT 3.5 T-PLT,0BL,3HL-HD 4HL-SHAFT 3.5 T-PLT, 4HL-HEAD 8HL-SHAFT QUARTER TUBULAR PLT, 4 HOLE 4.5 COBRA HEAD PLT, 10HLX202MM 3.5 T-PLT,0BL,3HL-HD 3HL-SHAFT 4.5 T-PLT, 6 HOLE 3.5 T-PLT, 4HL-HEAD 6HL-SHAFT ONE-THIRD TUBULAR PLT,9 HOLE 3.5 T-PLT, 3HL-HEAD 3HL-SHAFT 2.7 L-PLT, OBLIQUE RIGHT SEMI-TUBULAR PLT, 4 HOLE 3.5 T-PLT, 4HL-HEAD 4HL-SHAFT SEMI-TUBULAR PLT, 10 HOLE 2.7 L-PLT, OBLIQUE LEFT 4.5 T-PLT, 3 HOLE 2.7 L-PLT, RIGHT ONE-THIRD TUBULAR PLT,3 HOLE ONE-THIRD TUBULAR PLT, 2 HOLE SEMI-TUBULAR PLT, 2 HOLE ONE-THIRD TUBULAR PLT,4 HOLE SEMI-TUBULAR PLT, 11 HOLE ONE-THIRD TUBULAR PLT,5 HOLE ONE-THIRD TUBULAR PLT,8 HOLE SEMI-TUBLAR PLT, 9 HOLE SEMI-TUBULAR PLT, 8 HOLE SEMI-TUBULAR PLT, 5 HOLE SEMI-TUBULAR PLT, 3 HOLE SEMI-TUBULAR PLT, 6 HOLE ONE-THIRD TUBULAR PLT,7 HOLE SEMI-TUBULAR PLT, 7 HOLE ONE-THIRD TUBULAR PLT,6 HOLE SEMI-TUBULAR PLT, 12 HOLE CURVED 3.5MM PLATE 16 HOLE, NON-STERILE CURVED 3.5MM PLATE 24 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 6 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 15 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 5 HOLE, NON-STERILE CURVED 3.5MM PLATE 10 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 16 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 10 HOLE NON-STERILE CURVED 3.5MM PLATE 6 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 9 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 12 HOLE NON-STERILE CURVED 3.5MM PLATE 18 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 20 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 14 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 11 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 8 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 4 HOLE, NON-STERILE CURVED 3.5MM PLATE 20 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 3 HOLE, NON-STERILE CURVED 3.5MM PLATE 14 HOLE, NON-STERILE CURVED 3.5MM PLATE 12 HOLE, NON-STERILE CURVED 3.5MM PLATE 8 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 7 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 18 HOLE NON-STERILE STRAIGHT 3.5MM PLATE 13 HOLE NON-STERILE CURVED 3.5MM PLATE 22 HOLE, NON-STERILE STRAIGHT 3.5MM PLATE 22 HOLE NON-STERILE Peripheral removal screw dia. 0.16" x L 0.755" ZIMMER Nail Length Gauge ZIMMER Free Hand Tissue Protection Sleeve ZIMMER Long Cannulated Depth Gauge ZIMMER Free Hand targeting Depth Gauge ZIMMER Slap Hammer Adapter ZIMMER Extraction Adapter Cannulated Tall ZIMMER Extraction Adapter Cannulated ZIMMER 2MM PIN ZIMMER 3MM THREADED PIN ZIMMER 3mm Threaded Pin Surgical Guide Nitinol Blunt Tip, 1.6mmx510mm Surgical Guide Nitinol Trocar Tip, 1.4mmx510mm Surgical Guide Nitinol Trocar Tip, 1.6mmx510mm Surgical Guide Nitinol Blunt Tip, 1.4mmx510mm 01-1005-0008 Cannulated Countersink2.4/6 03-1006-0104 .25" SPICA SEAT, SPICA TABLE 03-1006-0401 SPICA TABLE ARM BAR, DOUBLE WIDTH S322210 Drill Guide for 2.7 Compression Plates 09-1010-010 DOUBLE DRILL GUIDE 3.2/1.60 MM 03-1006-0400 SPICA ARM-BAR, SPICA TABLE 01-1006-0001 SPICA TABLE ASSEMBLY Bone Plates and Screws GUIDE WIRE PUSHER GUIDE WIRE GRIPPER PERI CANNULATED CONICAL SCREW 3.5MM X 50MM, STERILE PERI CANNULATED CONICAL SCREW 3.5MM X 35MM, STERILE PERI CANNULATED CONICAL SCREW 3.5MM X 45MM, STERILE PERI CANNULATED CONICAL SCREW 3.5MM X 40MM, STERILE BONE PLATE SCREW ZIMMER Ruler Syntec Osteo-plate and screw Fixation VPPL-5-8 VPPR-5-8 182-1-10020 Humeral Nail Washer, SFP 3.5 MM RECONSTRUCTION PLATE, 20 HOLE ZIMMER Long Screw Cann 8mm PELVIC RECON PLATE BENDERS ZIMMER Pin Wrench 11mm Head 3.3MM FREE HAND TARG DRILL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-09-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-09-21
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2022-07-20
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-08-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-08-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-17
HWB	Extractor	Orthopedic	Class 1	888.4540	2015-09-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-20
HWA	Impactor	Orthopedic	Class 1	888.4540	2023-01-06
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-07-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-08-01
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2025-06-02
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-06-02
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2025-06-02
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2025-06-02
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-06-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2023-06-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-12-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-09-10
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2026-05-28
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2026-05-28
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2026-05-28
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Orthopedic	Class 2	888.3660	2026-05-28
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2026-05-28
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3650	2026-05-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-06-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-06-29
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2013-08-01
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2026-01-23
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2026-01-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-10-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2013-07-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-07-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-03-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-03-19
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2022-08-31
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-06-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-06-25
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-08-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-06-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-03-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-03-01
JDS	Nail, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-06-06
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-06-06
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-06-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-06-06
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2023-01-06
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2023-01-06
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-01-06
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2023-01-06
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3510	2023-01-06
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2023-01-06
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-01-06
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-01-06
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2025-06-02
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2025-06-02
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-08-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2021-03-05
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-08-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-07-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-07-20
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-11-30

Official Correspondent

PETER CHANG

US Agent Details

ROBERT WANG Email: rwang13@yahoo.com Phone: (909) 9971788

Related Public Records

Same Entity

Syntec Scientific Corporation

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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616944. Last updated year: 2026. Please use registration number 9616944 when referencing this establishment in official correspondence.