← Back to catalogue

RapidSorb

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
RapidSorb FDA UDI
Generic Name
Craniofacial bone tack, bioabsorbable FDA UDI
Device Name
RAPIDSORB IPS STERILITY SHIELD FDA UDI
Model / Reference
530.554 FDA UDI
Description
RAPIDSORB IPS STERILITY SHIELD FDA UDI

Identifiers

Catalog Number
530554 FDA UDI
Primary DI / UDI-DI
10887587057279 FDA UDI
510(k) Number
K141385 FDA UDI
FDA Product Code
HBW FDA UDI
GMDN Term
Craniofacial bone tack, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Craniofacial bone tack, bioabsorbableSurgical power tool battery-exchange sterility cover

RapidSorb by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool battery-exchange sterility cover.

Cleared under the same submission

K141385 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI cf4ff397-1bd1-48dc-80a3-e5f16213f8ac 36 fields · synced Jun 1, 2026