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Pectus System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
PECTUS SYSTEM FDA UDI
Generic Name
Funnel chest remodelling bar FDA UDI
Model / Reference
PT-2750 FDA UDI

Identifiers

Primary DI / UDI-DI
00841036257590 FDA UDI
510(k) Number
K061384 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Funnel chest remodelling bar FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Funnel chest remodelling bar

The PECTUS SYSTEM is a non-sterile implantable device designed to reduce the deformity of pectus excavatum (funnel chest) in pediatric patients. This single-patient device is made of metal, such as stainless steel or titanium, and can be anchored with wires or stabilizer plates on the rib cage.

Similar devices

Also classified as Funnel chest remodelling bar.

Cleared under the same submission

K061384 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI 69897781-f4a0-412c-a435-86f38a27ba8f 34 fields · synced Aug 4, 2026