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CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)

FDA UDI

Class II (US FDA UDI)

by Ossaware Biotech Co., Ltd.

Identity

Trade Name
CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS) FDA UDI
Generic Name
Cranial bone flap fixation clip FDA UDI
Device Name
CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS) FDA UDI
Model / Reference
9903.0101.15S FDA UDI
Description
CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile (3 PCS) FDA UDI

Identifiers

Catalog Number
9903.0101.15S FDA UDI
Primary DI / UDI-DI
04717002404175 FDA UDI
510(k) Number
K192310 FDA UDI
FDA Product Code
GXR FDA UDI
GMDN Term
Cranial bone flap fixation clip FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5250 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Cranial bone flap fixation clip

CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS) by Ossaware Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Cranial bone flap fixation clip.

Cleared under the same submission

K192310 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ossaware Biotech Co., Ltd.

Sources (1)

  • FDA UDI ea4a5e4b-8dd6-460c-8140-bd466a0d57da 36 fields · synced May 29, 2026