Alta™ Stand-Alone Interbody Fusion System

404 catalogue numbers from 8409-1008, listed by Biomet Spine, United States, under Intervertebral Fusion Device With Integrated Fixation, Cervical. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26
5manufacturers in China registered for this device type
404catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVE
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Alta™ Stand-Alone Interbody Fusion System
Listed by Biomet Spine, United States
FDA product code OVE
Device type Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Record published 2020-06-27
Record revised 2025-01-03 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Alta™ Stand-Alone Interbody Fusion System
Catalogue number Size Status
8409-1008 Zero-Plate Ti 8mm In distribution
8417-0508 ACDF PEEK 5° 12X15X8MM In distribution
8409-1105 Half-Plate Cranial Ti 5mm In distribution
8417-0005 ACDF PEEK 0° 12X15X5MM In distribution
8416-3518 Screw Self-Drill Variable Ti ø3.5x18mm In distribution
8416-4016 Screw Self-Drill Variable Ti ø4.0x16mm In distribution
8412-0511 ACDF PEEK 5° 14X17X11MM In distribution
8417-0708 ACDF PEEK 7° 12X15X8MM In distribution
8416-4018 SCREW SELF-DRILL VARIABLE TI Ø4.0X18MM In distribution
8411-0012 ACDF PEEK 0° 13x15x12mm In distribution
8409-1011 Zero-Plate Ti 11mm In distribution
8409-1208 Full-Plate Ti 10° 8mm In distribution
8425-4014 Screw Self-Drill Fixed Ti ø4.0x14mm In distribution
8414-4012 Screw Self-Drill Fixed Ti ø4.0x12mm In distribution
8414-4014 Screw Self-Drill Fixed Ti ø4.0x14mm In distribution
8412-0506 ACDF PEEK 5° 14x17x6mm In distribution
8409-2109 Half-Plate Caudal Ti 9mm In distribution
8424-4016 Screw Self-Tap Fixed Ti ø4.0x16mm In distribution
8427-4012 SCREW SELF-DRILL VARIABLE TI Ø4.0X12MM In distribution
8411-0011 ACDF PEEK 0° 13x15x11mm In distribution
8427-3514 SCREW SELF-DRILL VARIABLE TI Ø3.5X14MM In distribution
8425-3518 SCREW SELF-DRILL FIXED TI Ø3.5X18MM In distribution
8417-0011 ACDF PEEK 0° 12X15X11MM In distribution
8412-0705 ACDF PEEK 7° 14X17X5MM In distribution
8412-0512 ACDF PEEK 5° 14x17x12mm In distribution
8405-0000 Locking Cap Ti In distribution
8411-0711 ACDF PEEK 7° 13x15x11mm In distribution
8416-3518 SCREW SELF-DRILL VARIABLE TI Ø3.5X18MM In distribution
8406-4014 SCREW SELF-TAP VARIABLE TI Ø4.0X14MM In distribution
8404-4018 Screw Self-Tap Fixed Ti ø4.0x18mm In distribution
8405-0205 LOCKING CAP TI 2.0 HIGH ANGLE In distribution
8417-0511 ACDF PEEK 5° 12X15X11MM In distribution
8412-0707 ACDF PEEK 7° 14x17x7mm In distribution
8411-0510 ACDF PEEK 5° 13x15x10mm In distribution
8417-0711 ACDF PEEK 7° 12x15x11mm In distribution
8409-0006 Zero-Plate Ti 6mm In distribution
8409-0209 FULL-PLATE TI 9MM In distribution
8409-0010 Zero-Plate Ti 10mm In distribution
8406-4014 Screw Self-Tap Variable Ti ø4.0x14mm In distribution
8411-0505 ACDF PEEK 5° 13x15x5mm In distribution
8405-0202 Locking Cap Ti 1.25 high angle In distribution
8426-3514 Screw Self-Tap Variable Ti ø3.5x14mm In distribution
8406-4018 SCREW SELF-TAP VARIABLE TI Ø4.0X18MM In distribution
8417-0505 ACDF PEEK 5° 12x15x5mm In distribution
8409-1106 HALF-PLATE CRANIAL TI 6MM In distribution
8404-4014 Screw Self-Tap Fixed Ti ø4.0x14mm In distribution
8409-0108 Half-Plate Ti 8mm In distribution
8414-3518 Screw Self-Drill Fixed Ti ø3.5x18mm In distribution
8409-0206 Full-Plate Ti 6mm In distribution
8424-4014 SCREW SELF-TAP FIXED TI Ø4.0X14MM In distribution
8409-0212 Full-Plate Ti 12mm In distribution
8417-0707 ACDF PEEK 7° 12X15X7MM In distribution
8409-1008 ZERO-PLATE TI 8MM In distribution
8405-1000 Locking Cap Ti In distribution
8411-0506 ACDF PEEK 5° 13X15X6MM In distribution
8425-3516 SCREW SELF-DRILL FIXED TI Ø3.5X16MM In distribution
8412-0509 ACDF PEEK 5° 14x17x9mm In distribution
8412-0010 ACDF PEEK 0° 14x17x10mm In distribution
8416-3512 SCREW SELF-DRILL VARIABLE TI Ø3.5X12MM In distribution
8417-0509 ACDF PEEK 5° 12X15X9MM In distribution
8409-1207 FULL-PLATE TI 10° 7MM In distribution
8411-0009 ACDF PEEK 0° 13x15x9mm In distribution
8405-1000 LOCKING CAP TI In distribution
8404-4012 Screw Self-Tap Fixed Ti ø4.0x12mm In distribution
8411-0508 ACDF PEEK 5° 13x15x8mm In distribution
8416-4012 SCREW SELF-DRILL VARIABLE TI Ø4.0X12MM In distribution
8406-3514 SCREW SELF-TAP VARIABLE TI Ø3.5X14MM In distribution
8427-3518 SCREW SELF-DRILL VARIABLE TI Ø3.5X18MM In distribution
8409-2110 Half-Plate Caudal Ti 10mm In distribution
8425-3512 SCREW SELF-DRILL FIXED TI Ø3.5X12MM In distribution
8411-0710 ACDF PEEK 7° 13X15X10MM In distribution
8412-0711 ACDF PEEK 7° 14X17X11MM In distribution
8409-1106 Half-Plate Cranial Ti 6mm In distribution
8417-0010 ACDF PEEK 0° 12x15x10mm In distribution
8426-4012 Screw Self-Tap Variable Ti ø4.0x12mm In distribution
8426-3516 Screw Self-Tap Variable Ti ø3.5x16mm In distribution
8414-3514 Screw Self-Drill Fixed Ti ø3.5x14mm In distribution
8412-0008 ACDF PEEK 0° 14x17x8mm In distribution
8409-1111 HALF-PLATE CRANIAL TI 11MM In distribution
8409-0207 FULL-PLATE TI 7MM In distribution
8412-0712 ACDF PEEK 7° 14x17x12mm In distribution
8411-0008 ACDF PEEK 0° 13X15X8MM In distribution
8409-1012 ZERO-PLATE TI 12MM In distribution
8409-0105 Half-Plate Ti 5mm In distribution
8412-0005 ACDF PEEK 0° 14X17X5MM In distribution
8425-4012 Screw Self-Drill Fixed Ti ø4.0x12mm In distribution
8409-2108 HALF-PLATE CAUDAL TI 8MM In distribution
8409-2107 Half-Plate Caudal Ti 7mm In distribution
8411-0006 ACDF PEEK 0° 13X15X6MM In distribution
8425-4012 SCREW SELF-DRILL FIXED TI Ø4.0X12MM In distribution
8409-1107 HALF-PLATE CRANIAL TI 7MM In distribution
8426-3512 SCREW SELF-TAP VARIABLE TI Ø3.5X12MM In distribution
8416-3516 Screw Self-Drill Variable Ti ø3.5x16mm In distribution
8417-0707 ACDF PEEK 7° 12x15x7mm In distribution
8404-3512 Screw Self-Tap Fixed Ti ø3.5x12mm In distribution
8425-3512 Screw Self-Drill Fixed Ti ø3.5x12mm In distribution
8416-4016 SCREW SELF-DRILL VARIABLE TI Ø4.0X16MM In distribution
8404-4014 SCREW SELF-TAP FIXED TI Ø4.0X14MM In distribution
8417-0011 ACDF PEEK 0° 12x15x11mm In distribution
8424-3512 SCREW SELF-TAP FIXED TI Ø3.5X12MM In distribution
8425-3516 Screw Self-Drill Fixed Ti ø3.5x16mm In distribution
8427-4018 Screw Self-Drill Variable Ti ø4.0x18mm In distribution
8414-3516 Screw Self-Drill Fixed Ti ø3.5x16mm In distribution
8411-0010 ACDF PEEK 0° 13x15x10mm In distribution
8405-0202 LOCKING CAP TI 1.25 HIGH ANGLE In distribution
8409-0110 Half-Plate Ti 10mm In distribution
8417-0708 ACDF PEEK 7° 12x15x8mm In distribution
8424-4018 Screw Self-Tap Fixed Ti ø4.0x18mm In distribution
8411-0007 ACDF PEEK 0° 13X15X7MM In distribution
8424-4014 Screw Self-Tap Fixed Ti ø4.0x14mm In distribution
8417-0710 ACDF PEEK 7° 12X15X10MM In distribution
8411-0711 ACDF PEEK 7° 13X15X11MM In distribution
8409-0011 Zero-Plate Ti 11mm In distribution
8417-0508 ACDF PEEK 5° 12x15x8mm In distribution
8417-0709 ACDF PEEK 7° 12x15x9mm In distribution
8412-0011 ACDF PEEK 0° 14X17X11MM In distribution
8417-0512 ACDF PEEK 5° 12X15X12MM In distribution
8412-0705 ACDF PEEK 7° 14x17x5mm In distribution
8405-1202 Locking Cap Ti 1.25mm High Angle In distribution
8411-0707 ACDF PEEK 7° 13x15x7mm In distribution
8406-3514 Screw Self-Tap Variable Ti ø3.5x14mm In distribution
8412-0506 ACDF PEEK 5° 14X17X6MM In distribution
8412-0507 ACDF PEEK 5° 14X17X7MM In distribution
8411-0509 ACDF PEEK 5° 13x15x9mm In distribution
8405-1204 Locking Cap Ti 1.75mm High Angle In distribution
8424-3516 Screw Self-Tap Fixed Ti ø3.5x16mm In distribution
8409-2110 HALF-PLATE CAUDAL TI 10MM In distribution
8417-0511 ACDF PEEK 5° 12x15x11mm In distribution
8409-1009 ZERO-PLATE TI 9MM In distribution
8417-0009 ACDF PEEK 0° 12X15X9MM In distribution
8426-4014 SCREW SELF-TAP VARIABLE TI Ø4.0X14MM In distribution
8417-0705 ACDF PEEK 7° 12x15x5mm In distribution
8427-4014 Screw Self-Drill Variable Ti ø4.0x14mm In distribution
8409-1206 FULL-PLATE TI 10° 6MM In distribution
8409-1009 Zero-Plate Ti 9mm In distribution
8409-0111 Half-Plate Ti 11mm In distribution
8426-4016 Screw Self-Tap Variable Ti ø4.0x16mm In distribution
8409-1111 Half-Plate Cranial Ti 11mm In distribution
8427-4016 SCREW SELF-DRILL VARIABLE TI Ø4.0X16MM In distribution
8411-0708 ACDF PEEK 7° 13X15X8MM In distribution
8425-4014 SCREW SELF-DRILL FIXED TI Ø4.0X14MM In distribution
8409-0012 ZERO-PLATE TI 12MM In distribution
8409-0208 FULL-PLATE TI 8MM In distribution
8414-4012 SCREW SELF-DRILL FIXED TI Ø4.0X12MM In distribution
8409-2108 Half-Plate Caudal Ti 8mm In distribution
8409-0106 Half-Plate Ti 6mm In distribution
8411-0007 ACDF PEEK 0° 13x15x7mm In distribution
8409-1210 FULL-PLATE TI 10° 10MM In distribution
8409-2111 Half-Plate Caudal Ti 11mm In distribution
8412-0007 ACDF PEEK 0° 14X17X7MM In distribution
8411-0512 ACDF PEEK 5° 13x15x12mm In distribution
8426-4018 Screw Self-Tap Variable Ti ø4.0x18mm In distribution
8405-0000 LOCKING CAP TI In distribution
8412-0706 ACDF PEEK 7° 14x17x6mm In distribution
8411-0507 ACDF PEEK 5° 13x15x7mm In distribution
8411-0706 ACDF PEEK 7° 13x15x6mm In distribution
8427-3518 Screw Self-Drill Variable Ti ø3.5x18mm In distribution
8409-1110 Half-Plate Cranial Ti 10mm In distribution
8409-0105 HALF-PLATE TI 5MM In distribution
8409-0008 Zero-Plate Ti 8mm In distribution
8409-1012 Zero-Plate Ti 12mm In distribution
8412-0010 ACDF PEEK 0° 14X17X10MM In distribution
8406-3518 Screw Self-Tap Variable Ti ø3.5x18mm In distribution
8411-0010 ACDF PEEK 0° 13X15X10MM In distribution
8424-4018 SCREW SELF-TAP FIXED TI Ø4.0X18MM In distribution
8412-0712 ACDF PEEK 7° 14X17X12MM In distribution
8417-0008 ACDF PEEK 0° 12X15X8MM In distribution
8409-0209 Full-Plate Ti 9mm In distribution
8417-0710 ACDF PEEK 7° 12x15x10mm In distribution
8409-1205 Full-Plate Ti 10° 5mm In distribution
8409-1010 Zero-Plate Ti 10mm In distribution
8414-3514 SCREW SELF-DRILL FIXED TI Ø3.5X14MM In distribution
8412-0005 ACDF PEEK 0° 14x17x5mm In distribution
8416-4012 Screw Self-Drill Variable Ti ø4.0x12mm In distribution
8411-0510 ACDF PEEK 5° 13X15X10MM In distribution
8417-0712 ACDF PEEK 7° 12X15X12MM In distribution
8409-0109 Half-Plate Ti 9mm In distribution
8417-0706 ACDF PEEK 7° 12x15x6mm In distribution
8409-1005 Zero-Plate Ti 5mm In distribution
8409-1211 Full-Plate Ti 10° 11mm In distribution
8406-3518 SCREW SELF-TAP VARIABLE TI Ø3.5X18MM In distribution
8409-1209 FULL-PLATE TI 10° 9MM In distribution
8409-0207 Full-Plate Ti 7mm In distribution
8416-3514 SCREW SELF-DRILL VARIABLE TI Ø3.5X14MM In distribution
8412-0012 ACDF PEEK 0° 14X17X12MM In distribution
8424-3518 Screw Self-Tap Fixed Ti ø3.5x18mm In distribution
8426-3514 SCREW SELF-TAP VARIABLE TI Ø3.5X14MM In distribution
8417-0010 ACDF PEEK 0° 12X15X10MM In distribution
8417-0512 ACDF PEEK 5° 12x15x12mm In distribution
8406-3516 Screw Self-Tap Variable Ti ø3.5x16mm In distribution
8414-3512 SCREW SELF-DRILL FIXED TI Ø3.5X12MM In distribution
8417-0008 ACDF PEEK 0° 12x15x8mm In distribution
8409-1212 FULL-PLATE TI 10° 12MM In distribution
8417-0705 ACDF PEEK 7° 12X15X5MM In distribution
8427-4018 SCREW SELF-DRILL VARIABLE TI Ø4.0X18MM In distribution
8409-2105 HALF-PLATE CAUDAL TI 5MM In distribution
8424-4012 SCREW SELF-TAP FIXED TI Ø4.0X12MM In distribution
8412-0508 ACDF PEEK 5° 14x17x8mm In distribution
8412-0706 ACDF PEEK 7° 14X17X6MM In distribution
8409-0211 Full-Plate Ti 11mm In distribution
8411-0705 ACDF PEEK 7° 13X15X5MM In distribution
8405-1202 LOCKING CAP TI 1.25MM HIGH ANGLE In distribution
8409-0208 Full-Plate Ti 8mm In distribution
8414-4016 Screw Self-Drill Fixed Ti ø4.0x16mm In distribution
8411-0509 ACDF PEEK 5° 13X15X9MM In distribution
8411-0005 ACDF PEEK 0° 13X15X5MM In distribution
8417-0709 ACDF PEEK 7° 12X15X9MM In distribution
8409-2109 HALF-PLATE CAUDAL TI 9MM In distribution
8404-4012 SCREW SELF-TAP FIXED TI Ø4.0X12MM In distribution
8404-3518 SCREW SELF-TAP FIXED TI Ø3.5X18MM In distribution
8412-0708 ACDF PEEK 7° 14X17X8MM In distribution
8412-0707 ACDF PEEK 7° 14X17X7MM In distribution
8412-0505 ACDF PEEK 5° 14x17x5mm In distribution
8409-0010 ZERO-PLATE TI 10MM In distribution
8417-0007 ACDF PEEK 0° 12X15X7MM In distribution
8412-0505 ACDF PEEK 5° 14X17X5MM In distribution
8411-0705 ACDF PEEK 7° 13x15x5mm In distribution
8426-4018 SCREW SELF-TAP VARIABLE TI Ø4.0X18MM In distribution
8409-2107 HALF-PLATE CAUDAL TI 7MM In distribution
8424-4016 SCREW SELF-TAP FIXED TI Ø4.0X16MM In distribution
8404-3514 SCREW SELF-TAP FIXED TI Ø3.5X14MM In distribution
8411-0505 ACDF PEEK 5° 13X15X5MM In distribution
8412-0006 ACDF PEEK 0° 14x17x6mm In distribution
8409-0110 HALF-PLATE TI 10MM In distribution
8405-0205 Locking Cap Ti 2.0 high angle In distribution
8406-3512 SCREW SELF-TAP VARIABLE TI Ø3.5X12MM In distribution
8417-0510 ACDF PEEK 5° 12X15X10MM In distribution
8411-0709 ACDF PEEK 7° 13X15X9MM In distribution
8427-3514 Screw Self-Drill Variable Ti ø3.5x14mm In distribution
8409-0012 Zero-Plate Ti 12mm In distribution
8416-3516 SCREW SELF-DRILL VARIABLE TI Ø3.5X16MM In distribution
8412-0508 ACDF PEEK 5° 14X17X8MM In distribution
8409-0006 ZERO-PLATE TI 6MM In distribution
8405-0203 LOCKING CAP TI 1.5 HIGH ANGLE In distribution
8426-3516 SCREW SELF-TAP VARIABLE TI Ø3.5X16MM In distribution
8427-4016 Screw Self-Drill Variable Ti ø4.0x16mm In distribution
8409-0205 FULL-PLATE TI 5MM In distribution
8412-0012 ACDF PEEK 0° 14x17x12mm In distribution
8414-3518 SCREW SELF-DRILL FIXED TI Ø3.5X18MM In distribution
8409-1205 FULL-PLATE TI 10° 5MM In distribution
8412-0709 ACDF PEEK 7° 14X17X9MM In distribution
8405-1205 LOCKING CAP TI 2.00MM HIGH ANGLE In distribution
8409-1107 Half-Plate Cranial Ti 7mm In distribution
8417-0012 ACDF PEEK 0° 12X15X12MM In distribution
8414-4016 SCREW SELF-DRILL FIXED TI Ø4.0X16MM In distribution
8414-4014 SCREW SELF-DRILL FIXED TI Ø4.0X14MM In distribution
8409-1209 Full-Plate Ti 10° 9mm In distribution
8417-0005 ACDF PEEK 0° 12x15x5mm In distribution
8411-0012 ACDF PEEK 0° 13X15X12MM In distribution
8405-0204 LOCKING CAP TI 1.75 HIGH ANGLE In distribution

Showing 250 of 300 catalogue numbers.

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Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K152622 2016-07-08
K151064 2015-08-12

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