Exoshape

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name: EXOSHAPE FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM FDA UDI
Model / Reference: 1600-00-009 FDA UDI
Description: EXOSHAPE SOFT TISSUE FASTENER FEMORAL, 9 MM FDA UDI

Identifiers

Catalog Number: 1600-00-009 FDA UDI
Primary DI / UDI-DI: 20845854082147 FDA UDI
510(k) Number: K132783 FDA UDI
FDA Product Code: HWC FDA UDI
MBI FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Exoshape by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K132783 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Conmed Corporation

Sources (1)

FDA UDI 273f3117-f9f4-4c3f-9daa-b518033c5d95 36 fields · synced May 30, 2026