FDA.reportPublic FDA data

MaxAn® Anterior Cervical Plate System

Primary DI
00880304980105
Brand
MaxAn® Anterior Cervical Plate System
Company
BIOMET SPINE LLC
Model
14-522165
Catalog number
14-522165
Published
2021-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304980105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304980105008803049801058803049801050880304980105

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304860544Vitality®+ Osteotomy732M2129732M21292018-06-05
00880304860551Vitality®+ Osteotomy732M2221732M22212018-06-05
00880304860568Vitality®+ Osteotomy732M2224732M22242018-06-05
00880304860575Vitality®+ Osteotomy732M2226732M22262018-06-05
00880304860582Vitality®+ Osteotomy732M2229732M22292018-06-05
00888480489450LINEUM OCT SPINE SYSTEM14-52501314-5250132020-10-15
00888480511564LINEUM OCT SPINE SYSTEM14-52505414-5250542020-07-07
00888480207542POLARIS 5.5 SPINAL SYSTEM2000-23252000-23252015-10-24
00880304964143Polaris™ 6.35 Spinal System14-513730R14-513730R2020-11-10
00880304964433Polaris™ 6.35 Spinal System14-513555R14-513555R2020-11-10
03662663058155Spine System14-50077114-5007712021-12-17
03662663058162Spine System14-50077214-5007722021-12-17
03662663058179Spine System14-50077314-5007732021-12-17
03662663058186Spine System14-50077414-5007742021-12-17
03662663058193Spine System14-50077514-5007752021-12-17
03662663058209Spine System14-50077614-5007762021-12-17
03662663058216Spine System14-50077714-5007772021-12-17
03662663058223Spine System14-50077814-5007782021-12-17
03662663058230Spine System14-50077914-5007792021-12-17
03662663058247Spine System14-50078014-5007802021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-23
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.KWQ2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.KWQ2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.KWQ2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.KWQ2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.KWQ2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.KWQ2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.KWQ2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.KWQ2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168472SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00840606168502SAPPHIRE XSPINAL ELEMENTS, INC.KWQ2026-10-22
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-10-15
10889981214289MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214296MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214302MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214319MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214326MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214333MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214340MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214357MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214364MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214371MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214388MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214494MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214500MeridianSeaspine Orthopedics CorporationKWQ2020-12-30
10889981214517MeridianSeaspine Orthopedics CorporationKWQ2020-12-30