Consulting Wallah › Device Explorer › Other devices › Pectoral implant
Device Explorer · FDA GUDID · GMDN 48163

Pectoral implant

An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of si

US‑registered devices56in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile82%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Implantech Associates, Inc.3868%
Spectrum Designs Inc1832%

Top labelers

CompanyDevicesShare
Implantech Associates, Inc.3868%
Spectrum Designs Inc1832%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Spectrum Designs MedicalPowerflex™ Pectoral Implant, Novack Style 3, SDMPowerflex™ Pectoral Implant,Smooth (Novack StylePowerFlex™ Pectoral Implant SizerPowerflex™ Pectoral Implant, Novack Style 2, SDMPowerflex™ Pectoral Implant,Smooth (Novack StylePowerflex™ Pectoral Implant, Aiache Style 4, SDMPowerflex™ Pectoral Implant, Smooth (Aiache StylPowerflex™ Pectoral Implant, Aiache Style 1, SDM

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MICImplant, Muscle, Pectoralis92
MICImplant, muscle, pectoralis83
MIBElastomer, Silicone Block6

GMDN & GCC registration

  • GMDN code 48163 · implantable
  • Single‑use 100% · sterile 82% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many pectoral implant products are registered in the US?

56 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pectoral implant", from 2 companies. The largest labeler is Implantech Associates, Inc. with 68% of records.

Which FDA product codes apply?

MIC (Implant, Muscle, Pectoralis), MIC (Implant, muscle, pectoralis), MIB (Elastomer, Silicone Block)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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