A Link Z
A-Link Z is a lumbar interbody fusion family with anterior, anterolateral and lateral cage configurations. Titanium-alloy constructions and configurations with an optional PEEK interbody…
A-Link Z is a lumbar interbody fusion family with anterior, anterolateral and lateral cage configurations. Titanium-alloy constructions and configurations with an optional PEEK interbody component accommodate the selected approach and anatomy.
The PEEK components use tantalum markers for radiographic visibility. Cage shapes and sizes vary, and the implant is used with autograft and/or allogeneic cancellous or corticocancellous bone graft.
Listed Item
A Link Z Ti Unitary Far AL Interbody 28x10x13 7°
Fixation by Configuration
Anterior cages require the specified two vertebral-body screws for standalone use; four-hole models require the two medial screws with one superior and one inferior trajectory. Anterior constructs with fewer qualifying screws need additional fixation. Anterolateral and lateral cages require supplemental lumbosacral fixation.
3manufacturers in China registered for this device type
219catalogue 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.
| 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
| 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) | K201671 |
| Record published | 2021-12-03 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Sizes | Height 7 to 19 mm; angle 7 to 20 °; width 21 to 38 mm; length 20 to 38 mm; depth 10 to 30 mm; outer diameter 3 to 27 mm; length 6.55 to 13.39 in; height 13.032 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-000063 | In distribution | |
| 14-36261520 | Length 36 mm | In distribution |
| 10-621137 | Height 13 mm | In distribution |
| 15-32241407 | Length 32 mm | In distribution |
| 10-000035 | In distribution | |
| 13-328117 | Length 32 mm | In distribution |
| 10-000079 | In distribution | |
| 15-32241812 | Angle 12 ° | In distribution |
| 11-140003 | In distribution | |
| 16-28101307 | Height 13.0 mm | In distribution |
| 15-32241607 | Length 32 mm | In distribution |
| 10-621116 | Width 32 mm | In distribution |
| 11-002555 | Outer Diameter 5.5 mm | In distribution |
| 16-28100807 | Height 8.0 mm | In distribution |
| 14-36261116 | Length 36 mm | In distribution |
| 14-32211307 | Angle 7 ° | In distribution |
| 10-000067 | In distribution | |
| 11-328132 | Angle 12 ° | In distribution |
| 15-32241907 | Length 32 mm | In distribution |
| 15-32211112 | Length 32 mm | In distribution |
| 13-368132 | Length 36 mm | In distribution |
| 14-27271512 | Height 15.0 mm | In distribution |
| 14-38301107 | Length 38 mm | In distribution |
| 10-277157 | Outer Diameter 27 mm | In distribution |
| 10-000069 | In distribution | |
| 14-27271807 | Height 18.0 mm | In distribution |
| 14-36261112 | Length 36 mm | In distribution |
| 14-38301712 | Length 38 mm | In distribution |
| 13-368172 | Length 36 mm | In distribution |
| 14-27271312 | Height 13.0 mm | In distribution |
| 10-621152 | Height 15 mm | In distribution |
| 10-277176 | Outer Diameter 27 mm | In distribution |
| 10-277172 | Outer Diameter 27 mm | In distribution |
| 15-32211320 | Length 32 mm | In distribution |
| 14-32211316 | Angle 16 ° | In distribution |
| 10-000034 | In distribution | |
| 16-36261712 | Length 36 mm | In distribution |
| 15-32241107 | Length 32 mm | In distribution |
| 14-38301707 | Angle 7 ° | In distribution |
| 15-32241207 | Length 32 mm | In distribution |
| 10-277177 | Outer Diameter 27 mm | In distribution |
| 10-000033 | In distribution | |
| 14-38301916 | Length 38 mm | In distribution |
| 10-000039 | In distribution | |
| 14-32241512 | Length 32 mm | In distribution |
| 10-277137 | Outer Diameter 27 mm | In distribution |
| 10-000041 | In distribution | |
| 14-27271107 | Height 11.0 mm | In distribution |
| 11-300003 | In distribution | |
| 10-000065 | In distribution | |
| 11-328137 | Angle 7 ° | In distribution |
| 16-28100907 | Height 9.0 mm | In distribution |
| 13-368137 | Length 36 mm | In distribution |
| 13-368112 | Length 36 mm | In distribution |
| 16-36261112 | Length 36 mm | In distribution |
| 15-32241712 | Length 32 mm | In distribution |
| 14-27271307 | Height 13.0 mm | In distribution |
| 15-32211316 | Length 32 mm | In distribution |
| 15-32241212 | Length 32 mm | In distribution |
| 11-328112 | Angle 12 ° | In distribution |
| 15-32211307 | Length 32 mm | In distribution |
| 10-000055 | Length 12.5 in | In distribution |
| 14-32241712 | Length 32 mm | In distribution |
| 11-002550 | Outer Diameter 5.0 mm | In distribution |
| 14-32241707 | Length 32 mm | In distribution |
| 16-36261320 | Angle 20 ° | In distribution |
| 10-000061 | In distribution | |
| 15-32211520 | Length 32 mm | In distribution |
| 14-32211312 | Angle 12 ° | In distribution |
| 16-36261116 | Angle 16 ° | In distribution |
| 10-277097 | Outer Diameter 27 mm | In distribution |
| 10-277092 | Angle 12 ° | In distribution |
| 10-621150 | Height 15 mm | In distribution |
| 10-000053 | Length 12.63 in | In distribution |
| 15-32211720 | Length 32 mm | In distribution |
| 10-000059 | Length 13.2 in | In distribution |
| 13-328132 | Length 32 mm | In distribution |
| 15-32211912 | Length 32 mm | In distribution |
| 10-277132 | Outer Diameter 27 mm | In distribution |
| 14-27271707 | Height 17.0 mm | In distribution |
| 14-38301512 | Length 38 mm | In distribution |
| 11-003050 | Outer Diameter 5.5 mm | In distribution |
| 14-36261312 | Length 36 mm | In distribution |
| 10-000038 | In distribution | |
| 15-32211716 | Length 32 mm | In distribution |
| 13-368157 | Length 36 mm | In distribution |
| 13-368177 | Length 36 mm | In distribution |
| 10-000068 | In distribution | |
| 14-32211320 | Angle 20 ° | In distribution |
| 10-000042 | Length 6.55 in | In distribution |
| 10-277150 | Outer Diameter 27 mm | In distribution |
| 15-32241112 | Length 32 mm | In distribution |
| 10-000060 | Height 13.032 in | In distribution |
| 16-28101207 | Angle 7 ° | In distribution |
| 16-28101107 | Height 11.0 mm | In distribution |
| 14-38301307 | Angle 7 ° | In distribution |
| 11-328157 | Angle 7 ° | In distribution |
| 14-36261507 | Length 36 mm | In distribution |
| 14-38301520 | Length 38 mm | In distribution |
| 13-328157 | Length 32 mm | In distribution |
| 16-28100707 | Height 7.0 mm | In distribution |
| 14-32211107 | Angle 7 ° | In distribution |
| 16-36261720 | Angle 20 ° | In distribution |
| 10-277130 | Outer Diameter 27 mm | In distribution |
| 15-32241007 | Length 32 mm | In distribution |
| 10-000052 | In distribution | |
| 10-277170 | Outer Diameter 27 mm | In distribution |
| 10-000051 | In distribution | |
| 14-27271407 | Height 14.0 mm | In distribution |
| 14-27270907 | Angle 7 ° | In distribution |
| 14-32211112 | Angle 12 ° | In distribution |
| 16-36261520 | Angle 20 ° | In distribution |
| 14-27270912 | Height 9.0 mm | In distribution |
| 16-28101407 | Height 14.0 mm | In distribution |
| 14-36261316 | Length 36 mm | In distribution |
| 15-32241012 | Length 32 mm | In distribution |
| 16-28101007 | Height 10.0 mm | In distribution |
| 14-27271112 | Height 11.0 mm | In distribution |
| 14-38301312 | Length 38 mm | In distribution |
| 15-32241612 | Length 32 mm | In distribution |
| 14-32241316 | Length 32 mm | In distribution |
| 15-32241807 | Angle 7 ° | In distribution |
| 15-32241412 | Length 32 mm | In distribution |
| 15-32211712 | Length 32 mm | In distribution |
| 14-36261107 | Length 36 mm | In distribution |
| 14-27271612 | Height 16.0 mm | In distribution |
| 14-27271212 | Height 12.0 mm | In distribution |
| 14-32241507 | Length 32 mm | In distribution |
| 15-32211512 | Length 32 mm | In distribution |
| 14-36261916 | Length 36 mm | In distribution |
| 14-27271207 | Height 12.0 mm | In distribution |
| 15-32241307 | Length 32 mm | In distribution |
| 15-32211107 | Length 32 mm | In distribution |
| 15-32211516 | Length 32 mm | In distribution |
| 10-000066 | In distribution | |
| 10-621136 | Width 32 mm | In distribution |
| 15-32211507 | Length 32 mm | In distribution |
| 16-36261312 | Width 26 mm | In distribution |
| 15-32241507 | Length 32 µm | In distribution |
| 14-36261707 | Length 36 mm | In distribution |
| 14-36261920 | Length 36 mm | In distribution |
| 10-000016 | In distribution | |
| 14-36261712 | Angle 12 ° | In distribution |
| 11-328172 | Angle 12 ° | In distribution |
| 14-38301720 | Length 38 mm | In distribution |
| 15-32241707 | Length 32 mm | In distribution |
| 14-27271607 | Height 16.0 mm | In distribution |
| 15-32241912 | Angle 12 ° | In distribution |
| 10-277190 | Outer Diameter 27 mm | In distribution |
| 15-32211707 | Length 32 mm | In distribution |
| 11-270003 | In distribution | |
| 15-32241512 | Length 32 mm | In distribution |
| 14-36261720 | Angle 20 ° | In distribution |
| 10-277196 | Outer Diameter 27 mm | In distribution |
| 10-000062 | In distribution | |
| 10-000078 | In distribution | |
| 10-000014 | In distribution | |
| 13-328137 | Length 32 mm | In distribution |
| 10-000077 | In distribution | |
| 14-36261307 | Length 36 mm | In distribution |
| 14-32241716 | Length 32 mm | In distribution |
| 11-002050 | Outer Diameter 5.0 mm | In distribution |
| 10-000043 | In distribution | |
| 10-000076 | In distribution | |
| 10-621117 | Width 32 mm | In distribution |
| 10-277152 | Outer Diameter 27 mm | In distribution |
| 10-621170 | Height 17 mm | In distribution |
| 13-328112 | Length 32 mm | In distribution |
| 13-328152 | Length 32 mm | In distribution |
| 10-000056 | Length 13.39 in | In distribution |
| 10-000010 | In distribution | |
| 14-32211507 | Height 15.0 mm | In distribution |
| 14-36261716 | Angle 16 ° | In distribution |
| 10-277117 | Outer Diameter 27 mm | In distribution |
| 14-27271507 | Height 15.0 mm | In distribution |
| 10-000058 | Length 10.39 in | In distribution |
| 13-328172 | Length 32 mm | In distribution |
| 14-32241516 | Length 32 mm | In distribution |
| 10-621156 | Height 15 mm | In distribution |
| 10-277136 | Outer Diameter 27 mm | In distribution |
| 16-36261512 | Length 36 mm | In distribution |
| 16-36261316 | Angle 16 ° | In distribution |
| 14-27271712 | Height 17.0 mm | In distribution |
| 14-38301920 | Length 38 mm | In distribution |
| 10-000044 | In distribution | |
| 14-38301516 | Length 38 mm | In distribution |
| 11-360003 | In distribution | |
| 14-38301507 | Angle 7 ° | In distribution |
| 14-27271812 | Height 18.0 mm | In distribution |
| 11-002055 | Outer Diameter 5.5 mm | In distribution |
| 10-277192 | Outer Diameter 27 mm | In distribution |
| 10-000036 | In distribution | |
| 15-32211312 | Length 32 mm | In distribution |
| 13-368192 | Length 36 mm | In distribution |
| 10-621112 | Height 11 mm | In distribution |
| 10-277197 | Outer Diameter 27 mm | In distribution |
| 14-38301716 | Length 38 mm | In distribution |
| 10-000080 | In distribution | |
| 16-36261716 | Angle 16 ° | In distribution |
| 14-27271007 | Height 10.0 mm | In distribution |
| 16-36261516 | Angle 16 ° | In distribution |
| 10-277156 | Outer Diameter 27 mm | In distribution |
| 11-328152 | Angle 12 ° | In distribution |
| 10-000064 | In distribution | |
| 14-36261516 | Length 36 mm | In distribution |
| 10-277112 | Outer Diameter 27 mm | In distribution |
| 14-38301112 | Length 38 mm | In distribution |
| 15-32211920 | Length 32 mm | In distribution |
| 13-368117 | Length 36 mm | In distribution |
| 10-621130 | Width 32 mm | In distribution |
| 10-000037 | Outer Diameter 3 mm | In distribution |
| 15-32241312 | Length 32 mm | In distribution |
| 10-000057 | Length 11.54 in | In distribution |
| 10-621157 | Height 15 mm | In distribution |
| 14-27271412 | Height 14.0 mm | In distribution |
| 13-368152 | Length 36 mm | In distribution |
| 14-27271012 | Height 10.0 mm | In distribution |
| 14-38301316 | Length 38 mm | In distribution |
| 10-621132 | Width 32 mm | In distribution |
Same 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
| 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.
| 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.