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Thinflap System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
THINFLAP SYSTEM FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Model / Reference
91-6604-EA FDA UDI

Identifiers

Catalog Number
91-6604-EA FDA UDI
Primary DI / UDI-DI
00841036122898 FDA UDI
510(k) Number
K121589 FDA UDI
K121624 FDA UDI
K953385 FDA UDI
FDA Product Code
HBW FDA UDI
GWO FDA UDI
JEY FDA UDI
GXR FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5360 FDA UDI
882.5320 FDA UDI
872.4760 FDA UDI
882.5250 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Thinflap System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121589 also covers:

K121624 also covers:

K953385 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 dd10b175-91ff-4601-934b-44d2e9789348 36 fields · synced Jun 8, 2026