FDA.reportPublic FDA data

Segmental Plating System

Primary DI
00190376732022
Brand
Segmental Plating System
Company
ALPHATEC SPINE, INC.
Model
338-0216-S
Device description
SPS 2-Hole ACP, 16
Published
2026-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251965000Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.2025-08-28KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190376732022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190376732022001903767320221903767320220190376732022

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Contacts#

Phone, Email table
PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30
00190376544434Invictus17920-052026-07-30
00190376544441Invictus17920-062026-07-30
00190376544458Invictus17920-072026-07-30
00190376544465Invictus17920-082026-07-30
00190376544472Invictus17920-092026-07-30
00190376544489Invictus17920-102026-07-30
00190376544496Invictus179212026-07-30
00190376544502Invictus179222026-07-30
00190376544519Invictus179242026-07-30
00190376544861Invictus17920-112026-07-30
00190376544878Invictus17920-122026-07-30
00190376766133InvictusVMDCORT2026-07-30
00190376732008Segmental Plating System338-0214-S2026-07-27
00190376732015Segmental Plating System338-0215-S2026-07-27
00190376732039Segmental Plating System338-0217-S2026-07-27
00190376732046Segmental Plating System338-0218-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425481RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425498RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425504RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425511RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425528RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425535RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00840493425542RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-28
00190376732008Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732015Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732039Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732046Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732053Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732060Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732077Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732084Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732091Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732107Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732114Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27
00190376732121Segmental Plating SystemALPHATEC SPINE, INC.KWQ2026-07-27