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RapidSorb

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
RapidSorb FDA UDI
Generic Name
Bone/joint surgical power tool motor, electric FDA UDI
Device Name
RAPIDSORB IPS POWER DRIVE UNIT FDA UDI
Model / Reference
530.551 FDA UDI
Description
RAPIDSORB IPS POWER DRIVE UNIT FDA UDI

Identifiers

Catalog Number
530551 FDA UDI
Primary DI / UDI-DI
10887587057255 FDA UDI
510(k) Number
K141385 FDA UDI
FDA Product Code
HBW FDA UDI
GMDN Term
Bone/joint surgical power tool motor, electric 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

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

Category: Bone/joint surgical power tool motor, electricCraniofacial bone tack, bioabsorbable

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

Similar devices

Also classified as Craniofacial bone tack, bioabsorbable.

Cleared under the same submission

K141385 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 d82605e3-bdfb-4440-b004-df75343238ee 36 fields · synced May 30, 2026