Durango Alif System
ALIF PEEK Ti Marker 12.5° 27x36x16mm
3manufacturers in China registered for this device type
132catalogue numbers in this listing
5recalls 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 | Highridge Medical, 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 | Specification developer, Manufacturer |
| Record published | 2025-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8509-0212 | Device Size Text, specify—Full-Plate Ti 12mm | In distribution |
| 8505-0220 | Device Size Text, specify—Full-Plate Cover Ti 20mm | In distribution |
| 8510-4540 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø4.5 x 40mm | In distribution |
| 8513-0718 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 24x32x18mm | In distribution |
| 8515-1216 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 27x36x16mm | In distribution |
| 8515-0712 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 27x36x12mm | In distribution |
| 8512-0016 | Device Size Text, specify—ALIF PEEK 0° 27x36x16mm | In distribution |
| 8505-0016 | Device Size Text, specify—Zero-Plate Cover Ti 16mm | In distribution |
| 8512-0012 | Device Size Text, specify—ALIF PEEK 0° 27x36x12mm | In distribution |
| 8511-1214 | Device Size Text, specify—ALIF PEEK 12° 24x32x14mm | In distribution |
| 8511-1220 | Device Size Text, specify—ALIF PEEK 12° 24x32x20mm | In distribution |
| 8511-1218 | Device Size Text, specify—ALIF PEEK 12° 24x32x18mm | In distribution |
| 8515-0716 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 27x36x16mm | In distribution |
| 8509-0120 | Device Size Text, specify—Half-Plate Ti 20mm | In distribution |
| 8513-1214 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 24x32x14mm | In distribution |
| 8507-5035 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø5.0 x 35mm | In distribution |
| 8505-0216 | Device Size Text, specify—Full-Plate Cover Ti 16mm | In distribution |
| 8513-1520 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 24x32x20mm | In distribution |
| 8515-0720 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 27x36x20mm | In distribution |
| 8511-0014 | Device Size Text, specify—ALIF PEEK 0° 24x32x14mm | In distribution |
| 8509-0214 | Device Size Text, specify—Full-Plate Ti 14mm | In distribution |
| 8513-1220 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 24x32x20mm | In distribution |
| 8515-0718 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 27x36x18mm | In distribution |
| 8511-1512 | Device Size Text, specify—ALIF PEEK 15° 24x32x12mm | In distribution |
| 8515-0020 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 27x36x20mm | In distribution |
| 8510-4530 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø4.5 x 30mm | In distribution |
| 8505-0212 | Device Size Text, specify—Full-Plate Cover Ti 12mm | In distribution |
| 8509-0114 | Device Size Text, specify—Half-Plate Ti 14mm | In distribution |
| 8512-0716 | Device Size Text, specify—ALIF PEEK 7° 27x36x16mm | In distribution |
| 8512-1212 | Device Size Text, specify—ALIF PEEK 12° 27x36x12mm | In distribution |
| 8510-4520 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø4.5 x 20mm | In distribution |
| 8511-1212 | Device Size Text, specify—ALIF PEEK 12° 24x32x12mm | In distribution |
| 8511-0720 | Device Size Text, specify—ALIF PEEK 7° 24x32x20mm | In distribution |
| 8509-0216 | Device Size Text, specify—Full-Plate Ti 16mm | In distribution |
| 8515-0018 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 27x36x18mm | In distribution |
| 8511-0020 | Device Size Text, specify—ALIF PEEK 0° 24x32x20mm | In distribution |
| 8505-0116 | Device Size Text, specify—Half-Plate Cover Ti 16mm | In distribution |
| 8513-0018 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 24x32x18mm | In distribution |
| 8515-1512 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 27x36x12mm | In distribution |
| 8510-5025 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø5.0 x 25mm | In distribution |
| 8510-5035 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø5.0 x 35mm | In distribution |
| 8511-1520 | Device Size Text, specify—ALIF PEEK 15° 24x32x20mm | In distribution |
| 8515-1518 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 27x36x18mm | In distribution |
| 8512-0718 | Device Size Text, specify—ALIF PEEK 7° 27x36x18mm | In distribution |
| 8509-0016 | Device Size Text, specify—Zero-Plate Ti 16mm | In distribution |
| 8513-0714 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 24x32x14mm | In distribution |
| 8511-0016 | Device Size Text, specify—ALIF PEEK 0° 24x32x16mm | In distribution |
| 8511-0018 | Device Size Text, specify—ALIF PEEK 0° 24x32x18mm | In distribution |
| 8511-0012 | Device Size Text, specify—ALIF PEEK 0° 24x32x12mm | In distribution |
| 8513-0012 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 24x32x12mm | In distribution |
| 8509-0012 | Device Size Text, specify—Zero-Plate Ti 12mm | In distribution |
| 8509-0118 | Device Size Text, specify—Half-Plate Ti 18mm | In distribution |
| 8509-0018 | Device Size Text, specify—Zero-Plate Ti 18mm | In distribution |
| 8512-1218 | Device Size Text, specify—ALIF PEEK 12° 27x36x18mm | In distribution |
| 8517-0012 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 30x40x12mm | In distribution |
| 8510-4535 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø4.5 x 35mm | In distribution |
| 8515-1214 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 27x36x14mm | In distribution |
| 8512-0712 | Device Size Text, specify—ALIF PEEK 7° 27x36x12mm | In distribution |
| 8505-0112 | Device Size Text, specify—Half-Plate Cover Ti 12mm | In distribution |
| 8513-1218 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 24x32x18mm | In distribution |
| 8507-4535 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø4.5 x 35mm | In distribution |
| 8513-0712 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 24x32x12mm | In distribution |
| 8512-1516 | Device Size Text, specify—ALIF PEEK 15° 27x36x16mm | In distribution |
| 8509-0116 | Device Size Text, specify—Half-Plate Ti 16mm | In distribution |
| 8512-1520 | Device Size Text, specify—ALIF PEEK 15° 27x36x20mm | In distribution |
| 8507-5040 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø5.0 x 40mm | In distribution |
| 8509-0020 | Device Size Text, specify—Zero-Plate Ti 20mm | In distribution |
| 8512-0720 | Device Size Text, specify—ALIF PEEK 7° 27x36x20mm | In distribution |
| 8505-0214 | Device Size Text, specify—Full-Plate Cover Ti 14mm | In distribution |
| 8515-1212 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 27x36x12mm | In distribution |
| 8513-1216 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 24x32x16mm | In distribution |
| 8515-1516 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 27x36x16mm | In distribution |
| 8505-0218 | Device Size Text, specify—Full-Plate Cover Ti 18mm | In distribution |
| 8511-0718 | Device Size Text, specify—ALIF PEEK 7° 24x32x18mm | In distribution |
| 8505-0018 | Device Size Text, specify—Zero-Plate Cover Ti 18mm | In distribution |
| 8512-0014 | Device Size Text, specify—ALIF PEEK 0° 27x36x14mm | In distribution |
| 8505-0020 | Device Size Text, specify—Zero-Plate Cover Ti 20mm | In distribution |
| 8505-0114 | Device Size Text, specify—Half-Plate Cover Ti 14mm | In distribution |
| 8510-5030 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø5.0 x 30mm | In distribution |
| 8511-1516 | Device Size Text, specify—ALIF PEEK 15° 24x32x16mm | In distribution |
| 8510-4525 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø4.5 x 25mm | In distribution |
| 8512-1518 | Device Size Text, specify—ALIF PEEK 15° 27x36x18mm | In distribution |
| 8512-1216 | Device Size Text, specify—ALIF PEEK 12° 27x36x16mm | In distribution |
| 8512-0714 | Device Size Text, specify—ALIF PEEK 7° 27x36x14mm | In distribution |
| 8505-0118 | Device Size Text, specify—Half-Plate Cover Ti 18mm | In distribution |
| 8507-5025 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø5.0 x 25mm | In distribution |
| 8511-1518 | Device Size Text, specify—ALIF PEEK 15° 24x32x18mm | In distribution |
| 8511-0716 | Device Size Text, specify—ALIF PEEK 7° 24x32x16mm | In distribution |
| 8510-5040 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø5.0 x 40mm | In distribution |
| 8513-1212 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 24x32x12mm | In distribution |
| 8515-0016 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 27x36x16mm | In distribution |
| 8511-1216 | Device Size Text, specify—ALIF PEEK 12° 24x32x16mm | In distribution |
| 8513-1512 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 24x32x12mm | In distribution |
| 8510-5020 | Device Size Text, specify—Screw Var Aggr-Tip Ti Ø5.0 x 20mm | In distribution |
| 8512-1220 | Device Size Text, specify—ALIF PEEK 12° 27x36x20mm | In distribution |
| 8507-5030 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø5.0 x 30mm | In distribution |
| 8507-5020 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø5.0 x 20mm | In distribution |
| 8515-0012 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 27x36x12mm | In distribution |
| 8515-1514 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 27x36x14mm | In distribution |
| 8505-0120 | Device Size Text, specify—Half-Plate Cover Ti 20mm | In distribution |
| 8513-0020 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 24x32x20mm | In distribution |
| 8511-1514 | Device Size Text, specify—ALIF PEEK 15° 24x32x14mm | In distribution |
| 8512-0020 | Device Size Text, specify—ALIF PEEK 0° 27x36x20mm | In distribution |
| 8507-4520 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø4.5 x 20mm | In distribution |
| 8515-1520 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 27x36x20mm | In distribution |
| 8515-0014 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 27x36x14mm | In distribution |
| 8513-1514 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 24x32x14mm | In distribution |
| 8515-1218 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 27x36x18mm | In distribution |
| 8507-4530 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø4.5 x 30mm | In distribution |
| 8507-4525 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø4.5 x 25mm | In distribution |
| 8512-1514 | Device Size Text, specify—ALIF PEEK 15° 27x36x14mm | In distribution |
| 8517-0014 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 30x40x14mm | In distribution |
| 8513-1518 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 24x32x18mm | In distribution |
| 8505-0012 | Device Size Text, specify—Zero-Plate Cover Ti 12mm | In distribution |
| 8511-0712 | Device Size Text, specify—ALIF PEEK 7° 24x32x12mm | In distribution |
| 8513-0014 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 24x32x14mm | In distribution |
| 8515-1220 | Device Size Text, specify—ALIF PEEK Ti Marker 12.5° 27x36x20mm | In distribution |
| 8513-0016 | Device Size Text, specify—ALIF PEEK Ti Marker 0° 24x32x16mm | In distribution |
| 8513-0720 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 24x32x20mm | In distribution |
| 8512-0018 | Device Size Text, specify—ALIF PEEK 0° 27x36x18mm | In distribution |
| 8513-0716 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 24x32x16mm | In distribution |
| 8509-0112 | Device Size Text, specify—Half-Plate Ti 12mm | In distribution |
| 8513-1516 | Device Size Text, specify—ALIF PEEK Ti Marker 15° 24x32x16mm | In distribution |
| 8512-1214 | Device Size Text, specify—ALIF PEEK 12° 27x36x14mm | In distribution |
| 8512-1512 | Device Size Text, specify—ALIF PEEK 15° 27x36x12mm | In distribution |
| 8509-0014 | Device Size Text, specify—Zero-Plate Ti 14mm | In distribution |
| 8507-4540 | Device Size Text, specify—Screw Fixed Aggr-Tip Ti Ø4.5 x 40mm | In distribution |
| 8509-0220 | Device Size Text, specify—Full-Plate Ti 20mm | In distribution |
| 8515-0714 | Device Size Text, specify—ALIF PEEK Ti Marker 7.5° 27x36x14mm | In distribution |
| 8511-0714 | Device Size Text, specify—ALIF PEEK 7° 24x32x14mm | In distribution |
| 8509-0218 | Device Size Text, specify—Full-Plate Ti 18mm | In distribution |
| 8505-0014 | Device Size Text, specify—Zero-Plate Cover Ti 14mm | 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
Recalls
5 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 | Closed |
|---|---|---|---|---|---|
| 2016-02-12 | Class II | Mixed-up of materials/components | Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees. | 10 | 2016-05-10 |
| 2013-11-04 | Class II | Process control | Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver – Short (“Driver”) because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized. | 25 units | 2015-12-29 |
| 2013-08-22 | Class II | Component design/selection | The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. | 15 | 2015-03-13 |
| 2013-08-22 | Class II | Component design/selection | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft. | 12 units | 2015-03-13 |
| 2013-08-22 | Class II | Device Design | The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve. | 14 units | 2015-03-13 |
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.