FDA.reportPublic FDA data

ACP

Primary DI
00887517065148
Brand
ACP
Company
Nuvasive, Inc.
Model
18008314
Catalog number
18008314
Device description
ACP Screw, 3.5x14mm Self-Tap Variable
Published
2026-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K201078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201078000NuVasive® ACP SystemNu Vasive, Incorporated2020-05-20KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517065148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517065148008875170651488875170651480887517065148

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517127693MaXcess707042270704222026-07-27
00887517065100ACP18008223180082232026-04-25
00887517065124ACP18008312180083122026-04-25
00887517065162ACP18008316180083162026-04-25
00887517065186ACP18008318180083182026-04-25
00887517065384ACP18008512180085122026-04-25
00887517065612ACP18008622180086222026-04-25
00887517065643ACP18009117180091172026-04-25
00887517065667ACP18009119180091192026-04-25
00887517065681ACP18009121180091212026-04-25
00887517065926ACP18009229180092292026-04-25
00887517100412VuePoint897711589771152026-04-25
00887517156297ReLine11010511110105112026-04-25
00887517156822ReLine11010530110105302026-04-25
00887517378828CoRoent685121768512172026-04-25
00887517413673MAS PLIF707004270700422026-04-25
00887517645135CoRoent680050868005082026-04-25
00887517645142CoRoent680051068005102026-04-25
00887517645166CoRoent680051468005142026-04-25
00887517645173CoRoent680150868015082026-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-08-18
00810056995638corraCarlsmed, Inc.KWQ2026-08-17
00193982673475CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673499CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673505CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673529CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673536CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673550CREOGLOBUS MEDICAL, INC.KWQ2026-08-14
00193982673567CREOGLOBUS MEDICAL, INC.KWQ2026-08-14