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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 1.5MM FASTENER CARTRIDGE/SMALL-STERILE FDA UDI
Model / Reference
805.505.01S FDA UDI
Description
RAPIDSORB IPS 1.5MM FASTENER CARTRIDGE/SMALL-STERILE FDA UDI

Identifiers

Catalog Number
80550501S FDA UDI
Primary DI / UDI-DI
10887587061573 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

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: Craniofacial 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 2441ff7e-b8d4-4676-a3f3-195feacbd2a1 37 fields · synced Jun 8, 2026