ORTHO MAX INC

FDA Device Registration & Listing · Palm City, FL, US · Registration 3013843230

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
3013843230
FEI Number
3013843230
Entity Name
ORTHO MAX INC
City/State/Country
Palm City, FL, US
Establishment Address
4211 Sw High Meadows Ave, Palm City, FL 34990, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Ortho Max Inc (Owner Number: 10095220)
Owner / Operator Contact Address
4211 SW High Meadows Ave, Palm City, FL 34990, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K243740
PMA Number
N/A

All Registered Proprietary Names

GMReis MICRO ZIP ANCHOR 0,9mm w/ white #2-0 Stitch Suture and two needles 12,7mm 1/2 Circle Cylinder tip MINI ZIP ANCHOR 1,2mm w/white #1 Stitch suture and two needles 26,0mm 1/2 circle Diamond tip. MINI ZIP ANCHOR 1,2mm w/ 1,3mm white /blue STITCH TAPE and two needle 26,0mm 1/2 Circle DIAMOND TIP VERSA TORXDRIVE MINI SCREW 2.7x18mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx11mm TORXDRIVE LOCKING SCREW 2.4x24mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x08mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x40mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x22mm VERSA TORXDRIVE MINI SCREW TI 2,7x28mm VERSA TORXDRIVE MINI SCREW 2.7x30mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x28mm VERSA TORXDRIVE MINI SCREW 2.7x24mm VERSA TORXDRIVE MINI SCREW TI 2,7x18mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx15mm MINI VERSA TORXDRIVE SCREW TI 2mmx14mm MINI VERSA TORXDRIVE SCREW TI 2mmx24mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x10mm VERSA TORXDRIVE MINI SCREW TI 2,7x34mm VERSA TORXDRIVE MINI SCREW TI 2,7x30mm VERSA TORXDRIVE MINI SCREW 2.7x10mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x20mm TORXDRIVE LOCKING SCREW 2.4x14mm VERSA TORXDRIVE MINI SCREW TI 2,7x12mm VERSA TORXDRIVE MINI SCREW 2.4x20mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx24mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x14mm VERSALOCK TORXDRIVE LOCKING SCREW 2.4 x 20mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x16mm TORXDRIVE LOCKING SCREW 2.4x10mm TORXDRIVE LOCKING SCREW 2.4x20mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x30mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x12mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx18mm MINI VERSA TORXDRIVE SCREW TI 2mmx20mm VERSA SCREW TORXDRIVE 2.4x12mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x26mm VERSA TORXDRIVE MINI SCREW 2.4x16mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx20mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x10mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx16mm MINI VERSA TORXDRIVE SCREW TI 2mmx16mm VERSA TORXDRIVE MINI SCREW TI 2,7x36mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx17mm MINI VERSA TORXDRIVE SCREW TI 2mmx18mm VERSA TORXDRIVE MINI SCREW TI 2,7x32mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x24mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx13mm TORXDRIVE LOCKING SCREW 2.4x28mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx6mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx12mm VERSALOCK TORXDRIVE LOCKING SCREW 2.4 x 18mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x14mm MINI VERSA TORXDRIVE SCREW TI 2mmx22mm VERSA SCREW TORXDRIVE 2.4x30mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x28mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx7mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx14mm TORXDRIVE LOCKING SCREW 2.4x22mm VERSA TORXDRIVE MINI SCREW 2.7x12mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x26mm VERSA TORXDRIVE MINI SCREW 2.7x22mm TORXDRIVE LOCKING SCREW 2.4x18mm VERSA TORXDRIVE MINI SCREW TI 2,7x16mm VERSA TORXDRIVE MINI SCREW TI 2,7x40mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx10mm VERSALOCK TORXDRIVE LOCKING SCREW T7 2.7mmx20mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x18mm TORXDRIVE LOCKING SCREW 2.4x12mm VERSA TORXDRIVE MINI SCREW TI 2,7x10mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x32mm VERSA TORXDRIVE MINI SCREW 2.7x26mm VERSA TORXDRIVE MINI SCREW TI 2,7x20mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x34mm VERSA TORXDRIVE MINI SCREW 2.7x28mm VERSA TORXDRIVE MINI SCREW 2.7x20mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx12mm TORXDRIVE LOCKING SCREW 2.4x26mm VERSA TORXDRIVE MINI SCREW 2.4x14mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx18mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x22mm VERSA TORXDRIVE MINI SCREW 2.4x22mm MINI VERSA TORXDRIVE SCREW TI 2mmx10mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x16mm VERSA TORXDRIVE MINI SCREW TI 2,7x22mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx14mm TORXDRIVE LOCKING SCREW 2.4x30mm VERSA TORXDRIVE MINI SCREW 2.4x10mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx8mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx16mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x30mm VERSA TORXDRIVE MINI SCREW TI 2,7x38mm VERSA TORXDRIVE MINI SCREW 2.4x18mm MINI VERSALOCK TORXDRIVE SCREW T6 2mmx22mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x17mm VERSALOCK LOCKING SCREW TORXDRIVE 2.7x24mm TORXDRIVE LOCKING SCREW 2.4x16mm VERSA TORXDRIVE MINI SCREW TI 2,7x14mm VERSA TORXDRIVE MINI SCREW 2.4x26mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x36mm MINI VERSA TORXDRIVE SCREW TI 2mmx12mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x18mm VERSA TORXDRIVE MINI SCREW TI 2,7x24mm VERSA TORXDRIVE MINI SCREW 2.7x14mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx9mm VERSA TORXDRIVE MINI SCREW 2.4x28mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x38mm VERSALOCK TORXD. LOCKING SCREW T7 2.7x20mm VERSA TORXDRIVE MINI SCREW TI 2,7x26mm VERSA TORXDRIVE MINI SCREW 2.7x16mm MICRO VERSA TORXDRIVE SCREW TI 1.5mmx10mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x14mm T10 B. P VERSALOCK TORXDRIVE LOCKING SCREW 3.5x10mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x55mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x24mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x42mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x16mm T10 B. P VERSALOCK TORXDRIVE LOCKING SCREW 3.5x12mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x52mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5x14mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x65mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x26mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x16mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x60mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x26mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x10mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x16mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x32mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x16mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x48mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x22mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x28mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x70mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x08mm T10 B. P VERSALOCK TORXD. LOCKING SCREW T7 2.7x46mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x10mm T10 B. P VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x18mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x38mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x56mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x24mm T10 B. P VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x18mm T10 B. P VERSA TORXDRIVE LOW PROFILE SCREW 3.5x40mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x46mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x18mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x22mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x34mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x50mm VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x30mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x65mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x26mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x32mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x36mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x42mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x18mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x18mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x50mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x22mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x24mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x30mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x20mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x55mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x24mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x32mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x12mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x18mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x24mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x26mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x14mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x10mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x70mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x28mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x28mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x12mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x48mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x12mm T10 B. P VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x26mm T10 B. P VERSALOCK TORXD. LOCKING SCREW 3.5x30mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x12mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x28mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x24mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x58mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5x30mm T10 VERSALOCK TORXDRIVE LOCKING SCREW3.5x36mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x54mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x22mm T10 B. P VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x12mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x34mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x14mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x46mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x10mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x16mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x32mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x16mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x42mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x48mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x20mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x14mm T10 VERSA TORXDRIVE LOW PROFILE SCREW3.5x44mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x20mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x26mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x30mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x14mm T10 VERSA TORXDRIVE LOW PROFILE SCREW3.5x22mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5/2.7x20mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x44mm VERSALOCK TORXDRIVE LOCKING SCREW 3.5x28mm T10 VERSA TORXDRIVE LOW PROFILE SCREW 3.5x38mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x44mm T10 VERSA TORXDRIVE SCREW LOW PROF. 3.5x20mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5x40mm T10 VERSALOCK TORXD. LOCKING SCREW T7 2.7x60mm VERSALOCK TORXD. LOCKING SCREW 3.5x10mm T10 VERSALOCK TORXDRIVE LOCKING SCREW 3.5/2.7x20mm T10 B. P VERSALOCK TORXDRIVE LOCKING SCREW 3.5x50mm T10 VERSALOCK TORXD. LOCKING SCREW 3.5x22mm T10 MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx16mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx17mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx18mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx8mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx15mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx11mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx12mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx14mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx7mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx10mm MICRO SCAPHOID VERSALOCK PLATE 1.5mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx6mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx13mm MICRO VERSALOCK TORXDRIVE SCREW T4 1.5mmx9mm VERSALOCK HOOK CLAVICLE PLATE RIGHT 9 mm 8 HOLES 2.7/3.5 mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE RIGHT MEDIUM 08 HOLES 3,5mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE RIGHT 06 HOLES 3,5mm VERSALOCK SUPERIOR LATERAL EXTRA-ARTICULAR CLAVICLE PLATE, RIGHT, 11 HOLES 2.7/3.5mm VERSALOCK MEDIAL DISTAL HUMERUS LEFT PLATE 09 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x50mm VERSALOCK VERSATILE OLECRANON PLATE LEFT 03 HOLES 2,7/3.5mm VERSALOCK SUPERIOR CLAVICLE PLATE LEFT 10 HOLES 3,5mm VERSALOCK MEDIAL DISTAL HUMERUS RIGHT PLATE 08 HOLES 2,7/3.5mm VERSALOCK RADIUS HEAD PLATE 10 HOLES 2,0mm VERSALOCK HOOK CLAVICLE PLATE LEFT 9 mm 8 HOLES 2.7/3.5 mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE LEFT MEDIUM 08 HOLES 3,5mm VERSALOCK POSTEROLATERAL DISTAL HUMERUS RIGHT PLATE 13 HOLES 2,7/3.5mm VERSALOCK OLECRANON TENSION BAND PLATE 06 HOLES 2,7/3.5mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE LEFT SMALL 08 HOLES 3,5mm VERSALOCK POSTEROLATERAL DISTAL HUMERUS LEFT PLATE 13 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x48mm VERSALOCK VERSATILE OLECRANON PLATE LEFT 05 HOLES 2,7/3.5mm VERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 06 HOLE 3,5mm VERSA TORXDRIVE MINI SCREW TI 2,7x58mm VERSALOCK RADIUS NECK PLATE 11 HOLES 2,0mm VERSALOCK OLECRANON PLATE 08 HOLES 2,7mm VERSA TORXDRIVE MINI SCREW TI 2,7x54mm VERSALOCK OLECRANON PLATE LEFT 06 HOLES 2,7mm VERSALOCK SUPERIOR CLAVICLE PLATE RIGHT10 HOLES 3,5mm VERSALOCK OLECRANON PLATE RIGHT 06 HOLES 2,7mm VERSALOCK VERSATILE OLECRANON PLATE LEFT 09 HOLES 2,7/3.5mm VERSALOCK SUPERIOR LATERAL CLAVICLE PLATE WITH ANTERIOR TAB RIGHT 12 HOLES 2.7/3.5mm VERSALOCK PROXIMAL HUMERUS PLATE 03 HOLES 3,5mm VERSALOCK RADIUS HEAD PLATE 26 HOLES 2,0mm VERSALOCK OLECRANON PLATE 06 HOLES 2,7mm VERSALOCK SUPERIOR LATERAL CLAVICLE PLATE WITH ANTERIOR TAB LEFT 12 HOLES 2.7/3.5mm VERSALOCK PROXIMAL HUMERUS PLATE 13 HOLES 3,5mm VERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 08 HOLES 3,5mm VERSALOCK POSTEROLATERAL DISTAL HUMERUS RIGHT PLATE 14 HOLES 2,7/3.5mm VERSALOCK VERSATILE OLECRANON PLATE RIGHT 03 HOLES 2,7/3.5mm VERSALOCK LATERAL ANTERIOR CLAVICLE PLATE 08 HOLES 2,7/3,5mm VERSALOCK SUPERIOR LATERAL EXTRA-ARTICULAR CLAVICLE PLATE, LEFT,12 HOLES 2.7/3.5mm VERSALOCK LATERAL DISTAL HUMERUS LEFT PLATE 09 HOLES 2,7/3.5mm VERSALOCK VERSATILE OLECRANON PLATE LEFT 11 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x42mm VERSALOCK VERSATILE OLECRANON PLATE RIGHT 05 HOLES 2,7/3.5mm VERSALOCK CENTRAL ANTERIOR CLAVICLE PLATE 04 HOLES 3,5mm VERSALOCK VERSATILE OLECRANON PLATE RIGHT 07 HOLES 2,7/3.5mm VERSALOCK SUPERIOR LATERAL EXTRA-ARTICULAR CLAVICLE PLATE, RIGHT, 10 HOLES 2.7/3.5mm VERSALOCK MEDIAL DISTAL HUMERUS LEFT PLATE 08 HOLES 2,7/3.5mm VERSALOCK VERSATILE OLECRANON PLATE LEFT 07 HOLES 2,7/3.5mm VERSALOCK SUPERIOR LATERAL EXTRA-ARTICULAR CLAVICLE PLATE, LEFT, 10 HOLES 2.7/3.5mm VERSALOCK MEDIAL DISTAL HUMERUS RIGHT PLATE 09 HOLES 2,7/3.5mm VERSALOCK RADIUS HEAD PLATE 16 HOLES 2,0mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE RIGHT SMALL 08 HOLES 3,5mm VERSALOCK PROXIMAL HUMERUS PLATE 09 HOLES 3,5mm VERSALOCK VERSATILE OLECRANON PLATE RIGHT 09 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x52mm VERSALOCK SUPERIOR LATERAL CLAVICLE PLATE WITH ANTERIOR TAB LEFT 14 HOLES 2.7/3.5mm VERSALOCK LATERAL DISTAL HUMERUS RIGHT PLATE 09 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x60mm VERSALOCK PROXIMAL HUMERUS PLATE 11 HOLES 3,5mm VERSALOCK SUPERIOR LATERAL CLAVICLE PLATE WITH ANTERIOR TAB RIGHT 14 HOLES 2.7/3.5mm VERSALOCK LATERAL DISTAL HUMERUS RIGHT PLATE 08 HOLES 2,7/3.5mm VERSALOCK SUPERIOR LATERAL EXTRA-ARTICULAR CLAVICLE PLATE, RIGHT,12 HOLES 2.7/3.5mm VERSALOCK LATERAL DISTAL HUMERUS LEFT PLATE 08 HOLES 2,7/3.5mm VERSALOCK VERSATILE OLECRANON PLATE RIGHT 11 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x56mm VERSALOCK OLECRANON PLATE RIGHT 08 HOLES 2,7mm VERSALOCK OLECRANON PLATE LEFT 08 HOLES 2,7mm VERSALOCK LATERAL ANTERIOR CLAVICLE PLATE 06 HOLES 2,7/3,5mm VERSA TORXDRIVE MINI SCREW TI 2,7x44mm VERSALOCK LATERAL ANTERIOR CLAVICLE PLATE 10 HOLES 2,7/3,5mm VERSALOCK POSTEROLATERAL DISTAL HUMERUS LEFT PLATE 14 HOLES 2,7/3.5mm VERSA TORXDRIVE MINI SCREW TI 2,7x46mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE LEFT 06 HOLES 3,5mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE RIGHT LARGE 08 FUROS 3,5mm VERSALOCK PROXIMAL HUMERUS PLATE 05 HOLES 3,5mm VERSALOCK MEDIAL SUPERIOR CLAVICLE PLATE LEFT LARGE 08 HOLES 3,5mm VERSALOCK PROXIMAL HUMERUS PLATE 07 HOLES 3,5mm

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-06-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-05-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-05-21

Official Correspondent

Eric Parkin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ortho Max Inc
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

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
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3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
8043862 AAP IMPLANTATE AG BERLIN, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013843230. Last updated year: 2026. Please use registration number 3013843230 when referencing this establishment in official correspondence.
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