FDA.reportPublic FDA data

Powerflex™ Pectoral Implant Sizer

Primary DI
M724ACPI3RSIZNS1
Brand
Powerflex™ Pectoral Implant Sizer
Company
IMPLANTECH ASSOCIATES, INC.
Model
ACPI-3R-SIZ
Catalog number
ACPI-3R-SIZ-NS
Device description
Powerflex™ Pectoral Implant Sizer
Published
2017-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MICImplant, Muscle, Pectoralis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MICImplant, Muscle, PectoralisEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952708000PECTORALIS IMPLANTSpirit Ridge Technologies1995-08-28FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M724ACPI3RSIZNS1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-block tissue reconstructive materialA non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-733-0833info@implantech.com

Regulatory Flags#

DUNS number
784664955
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M724MCTBL10GF11Silicone Block, Grey, Firm 50 (EZ)Size: 14.5cm x 7.7cm x 1.0 cmMCT-BL-1.0-GF12026-04-16
M724MCTBL10GF21Silicone Block, Grey, Firm 50 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-GF22026-04-16
M724MCTBL10OF1Silicone Block, Opaque, Firm 40 (EZ)Size: 13.6cm x 5.8cm x 1.0cmMCT-BL-1.0-OF2026-04-16
M724MCTBL13GM1Silicone Block, Grey, Medium 35 (EZ)Size: 15.0cm x 7.6cm x 1.3cmMCT-BL-1.3-GM2026-04-16
M724SMCOBL20FF1Silicone BlockSMCO-BL-2.0-FFSMCO-BL-2.0-FF2026-01-28
M724SMCOBL20OF1Silicone BlockSMCO-BL-2.0-OFSMCO-BL-2.0-OF2026-01-28
M724SMCOBL20OVS1Silicone BlockSMCO-BL-2.0-OVSSMCO-BL-2.0-OVS2026-01-28
M724SMCOBL20WF1Silicone BlockSMCO-BL-2.0-WFSMCO-BL-2.0-WF2026-01-28
M724SMCOBL20WVS1Silicone BlockSMCO-BL-2.0-WVSSMCO-BL-2.0-WVS2026-01-28
M724SLV6341Gelzone® Shoulder SleeveSLV634SLV6342023-06-22
M724NGBL20WMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-WM-EZ-NS2025-08-27
M724NGBL20CVFNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-CVF-NS2025-08-27
M724NGBL20FFEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FF-EZ-NS2025-08-27
M724NGBL20FMEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FM-EZ-NS2025-08-27
M724NGBL20FSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-FS-NS2025-08-27
M724NGBL20OVSNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-OVS-NS2025-08-27
M724NGBL20RFM30EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFM30-EZ-NS2025-08-27
M724NGBL20RFS15EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS15-EZ-NS2025-08-27
M724NGBL20RFS20EZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS20-EZ-NS2025-08-27
M724NGBL20RFSEZNS1Silicone Block 2.0Size: 14.9cm x 7.7cm x 2.0cmNG-BL-2.0-RFS-EZ-NS2025-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B4905002016Pectoral ImplantAartMIC2025-08-29
B49050020163Pectoral ImplantAartMIC2025-08-29
B4905002025Pectoral ImplantAartMIC2025-08-29
B4905002026Pectoral ImplantAartMIC2025-08-29
B4905002035Pectoral ImplantAartMIC2025-08-29
B4905002036Pectoral ImplantAartMIC2025-08-29
B4905003015Pectoral ImplantAartMIC2025-08-29
B4905003016Pectoral ImplantAartMIC2025-08-29
B4905003025Pectoral ImplantAartMIC2025-08-29
B4905003026Pectoral ImplantAartMIC2025-08-29
B4905004015Pectoral ImplantAartMIC2025-08-29
B4905004016Pectoral ImplantAartMIC2025-08-29
B4905004025Pectoral ImplantAartMIC2025-08-29
B4905004026Pectoral ImplantAartMIC2025-08-29
B4905004035Pectoral ImplantAartMIC2025-08-29
B4905004036Pectoral ImplantAartMIC2025-08-29
B4905004045Pectoral ImplantAartMIC2025-08-29
B4905004046Pectoral ImplantAartMIC2025-08-29
B4905001015Pectoral ImplantAartMIC2025-08-28
B4905001016Pectoral ImplantAartMIC2025-08-28
B4905001025Pectoral ImplantAartMIC2025-08-28
B4905001026Pectoral ImplantAartMIC2025-08-28
B4905001035Pectoral ImplantAartMIC2025-08-28
B4905001036Pectoral ImplantAartMIC2025-08-28
B4905001045Pectoral ImplantAartMIC2025-08-28
B4905001046Pectoral ImplantAartMIC2025-08-28
B4905001055Pectoral ImplantAartMIC2025-08-28
B4905001056Pectoral ImplantAartMIC2025-08-28
B4905001065Pectoral ImplantAartMIC2025-08-28
B4905001066Pectoral ImplantAartMIC2025-08-28