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OS2-C Compression Staple

by In2Bones SAS

510(k) K153395

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153395↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK153395 Date18 Feb 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153395 decided 18 Feb 2016 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
JDR
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OS2-C Compression Staple is a surgical orthopedic device classified as a compression staple, designed to approximate and secure bone fragments during orthopedic procedures. It provides mechanical stability to promote proper healing of fractures or osteotomies, particularly in long bones or joint reconstructions.

This device is supplied sterile and intended for single-use. It is regulated under the FDA’s 510(k) pathway with a Traditional review, classified under product code JDR (Orthopedic Devices, Bone Staples). Compliance with the EU MDR is also noted, ensuring adherence to stringent safety and performance standards. The staple is available in a standardized size as specified in the submission.

Devices cleared under K153395

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K153395
UDI-DISize and differences
OS2®-C T30 SP110
IN2BONES
T30 SP110 / T30 SP11003760225711149 —No longer on the market
OS2®-C T30 SP130
IN2BONES
T30 SP130 / T30 SP13003760225711156 —No longer on the market
OS2®-C T30 SP150
IN2BONES
T30 SP150 / T30 SP15003760225711163 —No longer on the market

Similar devices

Other devices filed under FDA product code JDR (Staple, Fixation, Bone).

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