FDA.reportPublic FDA data

CURE™ ACP

Primary DI
B167700001230
Brand
CURE™ ACP
Company
MEDITECH SPINE, LLC
Model
7-00001-23
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K160604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160604000Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC2016-07-01KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B167700001230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and 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). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
182698477
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B167900002250CURE IVIEW9-00002-252022-10-07
B167900002260CURE IVIEW9-00002-262022-10-07
B167900002270CURE IVIEW9-00002-272022-10-07
B167900002280CURE IVIEW9-00002-282022-10-07
B167900002290CURE IVIEW9-00002-292022-10-07
B167900002300CURE IVIEW9-00002-302022-10-07
B167900002310CURE IVIEW9-00002-312022-10-07
B167900002320CURE IVIEW9-00002-322022-10-07
B167900002330CURE IVIEW9-00002-332022-10-07
B167900002340CURE IVIEW9-00002-342022-10-07
B167900002350CURE IVIEW9-00002-352022-10-07
B167900002360CURE IVIEW9-00002-362022-10-07
B167900002370CURE IVIEW9-00002-372022-10-07
B167900002380CURE IVIEW9-00002-382022-10-07
B167900002390CURE IVIEW9-00002-392022-10-07
B167900002400CURE IVIEW9-00002-402022-10-07
B167900002410CURE IVIEW9-00002-412022-10-07
B167900002420CURE IVIEW9-00002-422022-10-07
B167900002430CURE IVIEW9-00002-432022-10-07
B167900002440CURE IVIEW9-00002-442022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263196Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263202Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263219Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263226Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263233Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263240Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263257Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263264Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263271Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263288Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263295Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263301Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263318Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263325Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263332Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02