FDA.reportPublic FDA data

Slimplicity Anterior Cervical Plate System

Primary DI
00840019904650
Brand
Slimplicity Anterior Cervical Plate System
Company
PRECISION SPINE, INC.
Model
ACP118
Catalog number
ACP118
Device description
Anterior Cervical Plate 1-Level 18mm
Published
2019-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K060025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060025000SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEMSpinal USA2006-04-18KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019904650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019904650008400199046508400199046500840019904650

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation implant/sterilization container setA collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019978156Reform Ti39-TM-454539-TM-45452026-10-19
00840019978163Reform Ti39-TM-552039-TM-55202026-10-19
00840019978170Reform Ti39-TM-552539-TM-55252026-10-19
00840019978187Reform Ti39-TM-553039-TM-55302026-10-19
00840019978194Reform Ti39-TM-553539-TM-55352026-10-19
00840019978200Reform Ti39-TM-554039-TM-55402026-10-19
00840019978217Reform Ti39-TM-554539-TM-55452026-10-19
00840019978224Reform Ti39-TM-555039-TM-55502026-10-19
00840019978231Reform Ti39-TM-555539-TM-55552026-10-19
00840019978248Reform Ti39-TM-556039-TM-55602026-10-19
00840019978255Reform Ti39-TM-652539-TM-65252026-10-19
00840019978262Reform Ti39-TM-653039-TM-65302026-10-19
00840019978279Reform Ti39-TM-653539-TM-65352026-10-19
00840019978286Reform Ti39-TM-654039-TM-65402026-10-19
00840019978293Reform Ti39-TM-654539-TM-65452026-10-19
00840019978309Reform Ti39-TM-655039-TM-65502026-10-19
00840019978316Reform Ti39-TM-655539-TM-65552026-10-19
00840019978323Reform Ti39-TM-656039-TM-65602026-10-19
00840019978330Reform Ti39-TM-753039-TM-75302026-10-19
00840019978347Reform Ti39-TM-753539-TM-75352026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914005Saber-C Body (PT), 15x18x5 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914012Saber-C Body (PT), 15x18x6 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914029Saber-C Body (PT), 15x18x7 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914036Saber-C Body (PT), 15x18x8 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914043Saber-C Body (PT), 15x18x9 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914050Saber-C Body (PT), 15x18x10 6 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914425Saber-C Body (PT), 14x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914432Saber-C Body (PT), 14x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914449Saber-C Body (PT), 14x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914456Saber-C Body (PT), 14x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914463Saber-C Body (PT), 14x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
00810017914654Saber-C Body (PT), 15x18x5 12 deg.ELEVATION SPINE, INC.KWQ2026-10-26
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