Orthopedic › ProstheticIntervertebral Fusion Device With Integrated Fixation, Lumbar

Align

Align Ti Lateral Interbody 18x50x10 12°, STERILE

Registry build 21.09.26
3manufacturers in China registered for this device type
339catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code

Who Else Makes It

Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVD
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53

Record

Regulatory record for Align
Listed by Acuity Surgical Devices, LLC, United States
FDA product code OVD
Device type Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Repacker / relabeller, Manufacturer
510(k) K221535
Record published 2024-01-31
Record revised 2025-07-14 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Sizes Angle 7 to 50 °; height 7 to 19 mm; length 18 to 55 mm; width 9 to 60 mm; outer diameter 5 to 27 mm; height 7 to 15 µm; length 18 to 22 µm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Align
Catalogue number Size Status
16-18401112 Length 18 µm In distribution
11-102055-SP Length 20 mm In distribution
16-18550812 Length 18 mm In distribution
16-18501012-SP In distribution
16-22401507-SP Length 22 mm In distribution
16-18401012 Length 18 mm In distribution
16-22401307 Length 22 mm In distribution
16-18401007 Length 18 mm In distribution
16-22550807 Length 22 mm In distribution
16-18501507 Length 18 mm In distribution
14-32211516-SP Length 32 mm In distribution
16-18401507-SP Length 18 mm In distribution
16-18501707 Length 18 mm In distribution
16-22501012-SP Length 22 mm In distribution
16-18501107-SP Length 18 mm In distribution
16-22550707-SP Length 22 mm In distribution
16-18501712-SP Length 18 mm In distribution
16-18501307 Length 18 mm In distribution
16-22601507-SP Length 22 mm In distribution
16-18501407-SP Length 18 mm In distribution
16-22451112-SP Length 22 mm In distribution
16-22601512-SP Length 22 mm In distribution
16-22501107 Length 22 mm In distribution
16-22450907 Length 22 mm In distribution
16-18501312 Length 18 mm In distribution
16-18451407 Length 18 mm In distribution
16-22600812-SP Length 22 mm In distribution
16-22501312-SP Length 22 mm In distribution
16-22501712 Length 22 mm In distribution
16-22550807-SP Length 22 mm In distribution
16-18450907-SP Length 18 mm In distribution
16-22601007-SP Length 22 mm In distribution
14-36261512-SP Length 36 mm In distribution
16-22401112-SP Length 22 mm In distribution
16-18451107-SP Length 18 mm In distribution
16-18450907 Length 18 mm In distribution
14-32211720-SP Length 32 mm In distribution
16-18400807 Length 18 mm In distribution
14-32211716-SP Length 32 mm In distribution
14-38301712-SP Length 38 mm In distribution
11-103055-SP Length 30 mm In distribution
16-18501012 Length 18 mm In distribution
14-32211312-SP Length 32 mm In distribution
14-27271707-SP Outer Diameter 27 mm In distribution
14-36261316-SP Length 36 mm In distribution
16-22451512 Length 22 mm In distribution
16-22551507 Length 22 mm In distribution
16-22551707 Length 22 mm In distribution
16-18451012 Length 18 mm In distribution
16-22451307 Length 22 mm In distribution
16-18550907-SP Length 18 mm In distribution
16-18450912-SP Length 18 mm In distribution
16-22450807 Length 22 mm In distribution
16-22551007-SP Length 22 mm In distribution
16-18501307-SP Length 18 mm In distribution
16-22451312-SP Length 22 mm In distribution
16-18450912 Length 18 mm In distribution
14-27271307-SP In distribution
16-22601712-SP Length 22 mm In distribution
14-38301512-SP Length 38 mm In distribution
16-18451007-SP Length 18 mm In distribution
16-18400912-SP Length 18 mm In distribution
16-22551107-SP Length 22 mm In distribution
16-18451207-SP Length 18 mm In distribution
16-22550912 Length 22 mm In distribution
12-32211516 Length 32 mm In distribution
16-18401507 Length 18 mm In distribution
14-36261507-SP Length 36 mm In distribution
14-27271912-SP Outer Diameter 27 mm In distribution
16-22600912-SP Height 9 mm In distribution
16-22401712-SP Length 22 mm In distribution
16-22501507 Length 22 mm In distribution
16-18451207 Length 18 mm In distribution
14-27271107-SP Outer Diameter 27 mm In distribution
14-36261312-SP Length 36 mm In distribution
16-22600707-SP Length 22 mm In distribution
16-18401312 Length 18 mm In distribution
16-18500707 Length 18 mm In distribution
14-36261516-SP Length 36 mm In distribution
16-22600807 Length 22 mm In distribution
16-22451507-SP Length 22 mm In distribution
16-18400707 Length 18 mm In distribution
14-38301307-SP Length 38 mm In distribution
16-18450707 Length 18 mm In distribution
16-18450707-SP Length 18 mm In distribution
16-18500907-SP Length 18 mm In distribution
11-102555-SP Length 25 mm In distribution
16-18551312-SP Length 18 mm In distribution
14-32211316-SP Length 32 mm In distribution
14-36261116-SP Length 36 mm In distribution
16-22601012-SP Length 22 mm In distribution
16-18400807-SP Length 18 mm In distribution
12-32211112 Length 32 mm In distribution
14-38301920-SP Length 38 mm In distribution
14-27271907-SP Outer Diameter 27 mm In distribution
16-22551007 Length 22 mm In distribution
16-18400912 Length 18 mm In distribution
16-18451712-SP Length 18 mm In distribution
16-22401312-SP Length 22 mm In distribution
12-32211512 Length 32 mm In distribution
16-18450807-SP Length 18 mm In distribution
14-38301516-SP Length 38 mm In distribution
16-18551307 Length 18 mm In distribution
16-22550812 Length 22 mm In distribution
16-18501112-SP Length 18 mm In distribution
16-22601012 Length 22 mm In distribution
16-22500807-SP Length 22 mm In distribution
16-22550912-SP Length 22 mm In distribution
16-22601312 Length 22 mm In distribution
16-22501007 Length 22 mm In distribution
16-22600707 Length 22 mm In distribution
16-18401107-SP Length 18 mm In distribution
16-22551512 Length 22 mm In distribution
16-18500807 Length 18 mm In distribution
16-18451707 Length 18 mm In distribution
16-22500907-SP Length 22 mm In distribution
16-22451707 Length 22 mm In distribution
16-22601112 Length 22 mm In distribution
16-18400812-SP Length 18 mm In distribution
16-18500812-SP Length 18 mm In distribution
16-22601307-SP Length 22 mm In distribution
16-22451107 Length 22 mm In distribution
14-27271507-SP Outer Diameter 27 mm In distribution
16-22451107-SP Length 22 mm In distribution
16-22551512-SP Length 22 mm In distribution
16-18451012-SP Length 18 mm In distribution
14-36261307-SP Length 36 mm In distribution
11-102550-SP Length 25 mm In distribution
16-18451307-SP Length 18 mm In distribution
12-32211712 Length 32 mm In distribution
16-22600912 Length 22 mm In distribution
16-18451312-SP Length 18 mm In distribution
16-22601112-SP Length 22 mm In distribution
16-22501512-SP Length 22 mm In distribution
16-22450812 Length 22 mm In distribution
16-18550912-SP Length 18 mm In distribution
16-22501712-SP Length 22 mm In distribution
16-18450812 Length 18 mm In distribution
16-18501407 Length 18 mm In distribution
14-32211916-SP Length 32 mm In distribution
16-18550812-SP Length 18 mm In distribution
14-36261520-SP Length 36 mm In distribution
16-22401307-SP Length 22 mm In distribution
14-36261112-SP Length 36 mm In distribution
14-38301112-SP Length 38 mm In distribution
16-22551307-SP Length 22 mm In distribution
16-22501307-SP Length 22 mm In distribution
16-22551707-SP Length 22 mm In distribution
16-22451307-SP Length 22 mm In distribution
16-22451712 Length 22 mm In distribution
16-18551007-SP Length 18 mm In distribution
16-22601707 Length 22 mm In distribution
14-38301107-SP Length 38 mm In distribution
16-18501207 Length 18 mm In distribution
16-18550807 Length 18 mm In distribution
16-18551012-SP Length 18 mm In distribution
16-22401512-SP Length 22 mm In distribution
16-22500707-SP Length 22 mm In distribution
16-18500812 Length 18 mm In distribution
14-38301720-SP Length 38 mm In distribution
16-22501107-SP Length 22 mm In distribution
16-22601107 Length 22 mm In distribution
16-22601307 Length 22 mm In distribution
16-18551307-SP Length 18 mm In distribution
16-18401107 Length 18 mm In distribution
12-32211320 Length 32 mm In distribution
16-18401707 Length 18 mm In distribution
16-22451512-SP Length 22 mm In distribution
16-22601312-SP Length 22 mm In distribution
16-22500907 Length 22 mm In distribution
14-27271112-SP Outer Diameter 27 mm In distribution
16-22501012 Length 22 mm In distribution
16-18551007 Length 18 mm In distribution
16-22500912-SP Length 22 mm In distribution
16-22401112 Length 22 mm In distribution
12-32211520 Length 32 mm In distribution
16-18501107 Length 18 mm In distribution
16-22450907-SP Length 22 mm In distribution
16-22601107-SP Length 22 mm In distribution
16-18500807-SP Length 18 mm In distribution
14-36261707-SP Length 36 mm In distribution
14-32211520-SP Length 32 mm In distribution
16-18551207-SP Length 18 mm In distribution
16-22501312 Length 22 mm In distribution
16-18551407 Length 18 mm In distribution
11-140003-SP In distribution
16-18501007 Length 18 mm In distribution
16-18550707-SP Length 18 mm In distribution
16-22401512 Length 22 mm In distribution
16-18501207-SP Length 18 mm In distribution
16-18501007-SP Length 18 mm In distribution
16-22550812-SP Length 22 mm In distribution
16-22500707 Length 22 mm In distribution
16-18451112 Length 18 mm In distribution
14-32211507-SP In distribution
16-22450707 Length 22 mm In distribution
16-22451012-SP Length 22 mm In distribution
14-32211712-SP Length 32 mm In distribution
14-36261107-SP Length 36 mm In distribution
16-22551112-SP Length 22 mm In distribution
16-22600812 Length 22 mm In distribution
16-22550707 Length 22 mm In distribution
16-18451312 Length 18 mm In distribution
16-22451112 Length 22 mm In distribution
16-22601007 Length 22 mm In distribution
16-18451107 Length 18 mm In distribution
14-38301507-SP Length 38 mm In distribution
14-38301716-SP Length 38 mm In distribution
16-22501512 Length 22 mm In distribution
12-32211307 Length 32 mm In distribution
16-22551012 Length 22 µm In distribution
16-18451307 Length 18 mm In distribution
16-18401007-SP Length 18 mm In distribution
16-22451507 Length 22 mm In distribution
16-22551312-SP Length 22 mm In distribution
14-36261712-SP Length 36 mm In distribution
16-22401312 Length 22 mm In distribution
12-32211707 Length 32 mm In distribution
16-22451007 Length 22 mm In distribution
16-22500807 Length 22 mm In distribution
16-18501712 Length 18 mm In distribution
14-32211512-SP Length 32 mm In distribution
16-18551107-SP Length 18 mm In distribution
14-32211307-SP Length 32 mm In distribution
12-32211716 Length 32 mm In distribution
35-50000001-2 In distribution
16-22450812-SP Length 22 mm In distribution
16-18401307-SP Length 18 mm In distribution
16-22451707-SP Length 22 mm In distribution
16-18400907-SP Length 18 mm In distribution
12-32211312 Length 32 mm In distribution
35-50000001-3 In distribution
16-18451407-SP Length 18 mm In distribution
16-18551312 Length 18 mm In distribution
16-22401707 Length 22 mm In distribution
16-18401712 Length 18 mm In distribution
16-18551112-SP Length 18 mm In distribution
16-22401712 Length 22 mm In distribution
16-22501112-SP Length 22 mm In distribution
12-32211107 Length 32 mm In distribution
12-32211316 Length 32 mm In distribution
16-22501007-SP Length 22 mm In distribution
14-27271312-SP Outer Diameter 27 mm In distribution
16-22451007-SP Length 22 mm In distribution
16-22551307 Length 22 mm In distribution
16-18401012-SP Length 18 mm In distribution
16-18451512-SP Length 18 mm In distribution
16-18500907 Length 18 mm In distribution
16-22401507 Length 22 mm In distribution
16-18451707-SP Length 18 mm In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sirion Astura Medical 1,465
IdentiTi Alphatec Spine, Inc. 1,372
EL Capitan Astura Medical 1,205
Zavation Zavation 1,157
Brigade Nuvasive, Inc. 1,005
Solar™ Interbody Fusion System Degen Medical 899
Zavation F3D Corpectomy Zavation 730
ROI-A Ldr Spine USA 552
Avenue L Ldr Spine USA 524
Transcend Nanotec Alphatec Spine, Inc. 485
Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology Titan Spine, LLC 462
Base Nuvasive, Inc. 462

Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K243386 2025-04-22
K222561 2022-09-23
K201671 2021-05-04

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2019-01-07 Class II Process control Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. A total of 27 lots producing 178 units
2019-01-07 Class II Process control Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. A total of 27 lots producing 178 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer