FDA Registration Active 🇲🇾 Malaysia

TI NON LOCK SCREW 2.4 X 12MM (5201124012)

Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
Products
2
Proprietary Names
103
Establishment Types
1
Classifications
2

Registration Details

Registration Name
Straits Orthopaedics (MFG) Sdn Bhd
Registration Number
3004889950
FEI Number
3004889950
Status
Active
Expiry Year
2025
Initial Importer
No
Address
2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
City
Bayan Lepas Pulau Pinang
Country
MY

Regulatory Submissions

510(k) Number
K090692

Owner / Operator

Firm Name
Straits Orthopaedics (Mfg) Sdn Bhd
Operator Number
10048319
Address
No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
City
Bayan Lepas
State
Pulau Pinang
Postal Code
11920
Country
MY
Correspondent
TH SU

Products

Device Name Product Code
Plate, Fixation, Bone HRS
Screw, Fixation, Bone HWC

Proprietary Names

TI NON LOCK SCREW 2.4 X 12MM (5201124012) TI NON LOCK SCREW 2.4 X 32MM (5201124032) TI LOCK SCREW 2.4 X 10MM (5201024010) TI LOCK SCREW 2 X 20MM (5201020020) TI NON LOCK SCREW 2.4 X 20MM (520S124020) TI LOCK SCREW 2.4 X 20MM (5201024020) TI LOCK SCREW 2 X 10MM (5201020010, 140421) TI NON LOCK SCREW 2.4 X 14MM (520S124014) TI NON LOCK SCREW 2 X 8MM (520S120008) TI LOCK SCREW 2.4 X 36MM (5201024036) TI NON LOCK SCREW 2.4 X 18MM (520S124018) TI LOCK SCREW 2.4 X 18MM (5201024018) TI LOCK SCREW 2.4 X 28MM (520S1024028) TI NON LOCK SCREW 2.4 X 24MM (5201124024) TI LOCK SCREW 2.4 X 40MM (5201024040) TI NON LOCK SCREW 2.4 X 26MM (520S124026) TI LOCK SCREW 2.4 X 24MM (520S1024024) TI NON LOCK SCREW 2 X 18MM (5201120018) TI NON LOCK SCREW 2.4 X 26MM (5201124026) TI LOCK SCREW 2 X 8MMORTHOLOC SYSTEM STERILE (520S020008) TI LOCK SCREW 2.4 X 16MM (5201024016) TI NON LOCK SCREW 2 X 14MM (520S120014) TI NON LOCK SCREW 2.4 X 22MM (520S124022) TI LOCK SCREW 2.4 X 12MM (520S1024012) TI LOCK SCREW 2 X 16MMORTHOLOC SYSTEM STERILE (520S020016) TI LOCK SCREW 2.4 X 26MM (5201024026) TI LOCK SCREW 2.4 X 20MM (520S1024020) LOCKING SCREW 4.5 X 35MMORTHOLOC 3DI PLATING SYSTEM (59214535) TI NON LOCK SCREW 2.4 X 34MM (5201124034) TI NON LOCK SCREW 2 X 10MM (5201120010) TI LOCK SCREW 2.4 X 8MM (5201024008) LOCKING SCREW 4.5 X 34MMORTHOLOC 3DI SYS STERILE (59S14534) TI LOCK SCREW 2.4 X 48MM (5201024048) TI NON LOCK SCREW 2.4 X 46MM (5201124046) TI NON LOCK SCREW 2.4 X 42MM (5201124042) TI LOCK SCREW 2.4 X 24MM (5201024024, 140435) TI LOCK SCREW 2 X 18MMORTHOLOC SYSTEM STERILE (520S020018) TI NON LOCK SCREW 2.4 X 36MM (5201124036) TI LOCK SCREW 2.4 X 28MM (5201024028, 140437) LOCKING SCREW 4.5 X 35MMORTHOLOC 3DI SYS STERILE (59S14535) TI NON LOCK SCREW 2.4 X 38MM (5201124038) TI NON LOCK SCREW 2.4 X 18MM (5201124018) TI NON LOCK SCREW 2 X 16MM (520S120016) TI NON LOCK SCREW 2.4 X 40MM (5201124040) TI LOCK SCREW 2.4 X 32MM (5201024032) TI LOCK SCREW 2 X 12MMORTHOLOC SYSTEM STERILE (520S020012) TI NON LOCK SCREW 2.4 X 22MM (5201124022) TI LOCK SCREW 2.4 X 12MM (5201024012) TI NON LOCK SCREW 2 X 12MM (5201120012, 140441) TI LOCK SCREW 2.4 X 18MM (520S1024018) TI NON LOCK SCREW 2.4 X 50MM (5201124050) TI NON LOCK SCREW 2.4 X 16MM (5201124016) TI LOCK SCREW 2.4 X 42MM (5201024042) TI LOCK SCREW 2.4 X 8MM (520S024008) 520S024018 TI LOCK SCREW 2.4 X 18MM ORTHOLOC™ SYSTEM STERILE TI LOCK SCREW 2.4 X 50MM (5201024050) TI LOCK SCREW 2.4 X 30MM (520S1024030) TI NON LOCK SCREW 2.4 X 12MM (520S124012) TI NON LOCK SCREW 2.4 X 14MM (5201124014) TI NON LOCK SCREW 2 X 10MM (520S120010) TI LOCK SCREW 2 X 14MM (5201020014) TI LOCK SCREW 2 X 10MMORTHOLOC SYSTEM STERILE (520S020010) TI LOCK SCREW 2 X 12MM (5201020012) TI LOCK SCREW 2.4 X 14MM (5201024014) TI NON LOCK SCREW 2.4 X 30MM (5201124030) TI LOCK SCREW 2.4 X 44MM (5201024044) TI LOCK SCREW 2 X 8MM (5201020008, 140420) TI LOCK SCREW 2.4 X 22MM (5201024022) TI LOCK SCREW 2.4 X 16MM (520S1024016) TI NON LOCK SCREW 2 X 20MM (520S120020) TI LOCK SCREW 2.4 X 34MM (5201024034) TI NON LOCK SCREW 2 X 16MM (5201120016) TI NON LOCK SCREW 2.4 X 28MM (520S124028) TI NON LOCK SCREW 2.4 X 28MM (5201124028) TI LOCK SCREW 2.4 X 46MM (5201024046) TI NON LOCK SCREW 2.4 X 20MM (5201124020) TI LOCK SCREW 2 X 20MMORTHOLOC SYSTEM STERILE (520S020020) TI NON LOCK SCREW 2.4 X 16MM (520S124016) TI LOCK SCREW 2.4 X 30MM ORTHOLOC™ SYSTEM STERILE (520S024030) TI LOCK SCREW 2 X 18MM (5201020018) TI NON LOCK SCREW 2 X 12MM (520S120012) TI NON LOCK SCREW 2.4 X 30MM (520S124030) TI LOCK SCREW 2 X 14MMORTHOLOC SYSTEM STERILE (520S020014) TI LOCK SCREW 2.4 X 14MM (520S1024014) TI NON LOCK SCREW 2 X 14MM (5201120014) TI NON LOCK SCREW 2.4 X 8MM (5201124008) TI NON LOCK SCREW 2.4 X 44MM (5201124044) TI NON LOCK SCREW 2 X 8MM (5201120008) TI NON LOCK SCREW 2 X 20MM (5201120020) TI NON LOCK SCREW 2.4 X 48MM (5201124048) TI LOCK SCREW 2.4 X 38MM (5201024038) TI LOCK SCREW 2.4 X 26MM (520S1024026) TI NON LOCK SCREW 2.4 X 8MM (520S124008) TI NON LOCK SCREW 2.4 X 10MM (5201124010) TI LOCK SCREW 2.4 X 30MM (5201024030, 140438) TI LOCK SCREW 2.4 X 22MM (520S1024022) TI NON LOCK SCREW 2.4 X 24MM (520S124024) TI LOCK SCREW 2 X 16MM (5201020016) TI NON LOCK SCREW 2 X 18MM (520S120018) TI LOCK SCREW 2.4 X 10MM (520S024010) TI NON LOCK SCREW 2.4 X 10MM (520S124010) 5201124024 Ti Non Lock Screw 2.4 X 24mm Ortholoc™ Plating System 5201124008 Ti Non Lock Screw 2.4 X 8mm Ortholoc™ Plating System

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)