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ChronOS

FDA UDI

by Synthes

Identity

Trade Name
ChronOS FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
CHRONOS(TM) BETA-TCP GRANULES 0.7-1.4MM/2.5CC-STERILE FDA UDI
Model / Reference
710.003.98S FDA UDI
Description
CHRONOS(TM) BETA-TCP GRANULES 0.7-1.4MM/2.5CC-STERILE FDA UDI

Identifiers

Catalog Number
71000398S FDA UDI
Primary DI / UDI-DI
10887587060774 FDA UDI
510(k) Number
K041350 FDA UDI
K053022 FDA UDI
FDA Product Code
LPK FDA UDI
FMF FDA UDI
GXP FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial FDA UDI

Classification

Regulation Number
880.5860 FDA UDI
882.5300 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

Category: Bone matrix implant, synthetic, non-antimicrobial

ChronOS by Synthes — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Cleared under the same submission

K041350 also covers:

K053022 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 513dede9-202b-4250-b487-164e22f994be 36 fields · synced Jun 1, 2026