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Inion CPS/OTPS instrumentation

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref INS-9071Ref INS-9009Ref INS-9040Ref INS-9076Ref INS-9079Ref INS-9265Ref INS-9082Ref INS-9011Ref INS-9030Ref INS-9060Ref INS-9084Ref INS-9014Ref INS-9264Ref INS-9078Ref INS-9114Model INS-9030 Ref INS-9081Ref INS-9060 Ref INS-9004Ref INS-9096Ref INS-9027Ref INS-9029Ref INS-9087Ref INS-9291Ref INS-9001Ref INS-9273Model INS-9087 Ref INS-9029 Ref INS-9040

by Inion Oy

Identity

Trade Name
Inion CPS/OTPS instrumentation EUDAMED
Inion CPS™/OTPS™ instrumentation FDA UDI
Inion® Universal instruments FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Surgical drill guide, reusable FDA UDI
Device Name
Inion CPS/OTPS instrumentation EUDAMED
Inion Instruments EUDAMED
Inion Universal instruments EUDAMED
1.60 mm drill bit short (J-latch) FDA UDI
K-wire 1.6 mm with depth gauge FDA UDI
2.10 mm drill bit short (J-latch) FDA UDI
1.60 mm drill bit with 22 mm stop (J-latch) FDA UDI
2.8 mm drill bit with 42 mm stop (AO-bayonet) FDA UDI
3.8 mm drill bit, cannulated FDA UDI
3.5 mm drill bit FDA UDI
1.75 mm drill bit with 6 mm stop (AO-bayonet) FDA UDI
2.35 mm drill bit long (J-latch) FDA UDI
2.10 mm drill bit with 11 mm stop (J-latch) FDA UDI
Model / Reference
INS-9071 EUDAMED
INS-9009 EUDAMED
INS-9040 EUDAMED
INS-9076 EUDAMED
INS-9079 EUDAMED
INS-9265 EUDAMED
INS-9082 EUDAMED
INS-9011 EUDAMED
INS-9030 EUDAMED
INS-9060 EUDAMED
INS-9084 EUDAMED
INS-9014 EUDAMED
INS-9264 EUDAMED
INS-9078 EUDAMED
INS-9114 EUDAMED
INS-9081 EUDAMED
INS-9004 EUDAMED
INS-9096 EUDAMED
INS-9027 EUDAMED
INS-9029 EUDAMED
INS-9087 EUDAMED
INS-9291 EUDAMED
INS-9001 EUDAMED
INS-9273 EUDAMED
1 FDA UDI
Description
1.60 mm drill bit short (J-latch) FDA UDI
K-wire 1.6 mm with depth gauge FDA UDI
2.10 mm drill bit short (J-latch) FDA UDI
1.60 mm drill bit with 22 mm stop (J-latch) FDA UDI
2.8 mm drill bit with 42 mm stop (AO-bayonet) FDA UDI
3.8 mm drill bit, cannulated FDA UDI
3.5 mm drill bit FDA UDI
1.75 mm drill bit with 6 mm stop (AO-bayonet) FDA UDI
2.35 mm drill bit long (J-latch) FDA UDI
2.10 mm drill bit with 11 mm stop (J-latch) FDA UDI

Identifiers

Catalog Number
INS-9001 FDA UDI
INS-9087 FDA UDI
INS-9009 FDA UDI
INS-9004 FDA UDI
INS-9076 FDA UDI
INS-9079 FDA UDI
INS-9078 FDA UDI
INS-9096 FDA UDI
INS-9014 FDA UDI
INS-9011 FDA UDI
Primary DI / UDI-DI
06438408001789 EUDAMED
06438408001635 EUDAMEDFDA UDI
06438408001987 EUDAMED
06438408001925 EUDAMEDFDA UDI
06438408001956 EUDAMEDFDA UDI
06438408002229 EUDAMED
06438408001932 EUDAMED
06438408001642 EUDAMEDFDA UDI
06438408000263 EUDAMED
06438408001550 EUDAMED
06438408001970 EUDAMED
06438408001697 EUDAMEDFDA UDI
06438408000287 EUDAMED
06438408001949 EUDAMEDFDA UDI
06438408001864 EUDAMED
06438408004506 EUDAMED
06438408001482 EUDAMEDFDA UDI
06438408001567 EUDAMEDFDA UDI
06438408000218 EUDAMED
06438408000294 EUDAMED
06438408002960 EUDAMEDFDA UDI
06438408001437 EUDAMED
06438408000249 EUDAMEDFDA UDI
06438408002090 EUDAMED
Basic UDI-DI
B-06438408001789 EUDAMED
B-06438408001635 EUDAMED
6438408INION-IR-INSTRUM9T EUDAMED
6438408INION-IIA-INSTRUUR EUDAMED
B-06438408002229 EUDAMED
B-06438408001970 EUDAMED
B-06438408001956 EUDAMED
B-06438408001697 EUDAMED
B-06438408001949 EUDAMED
B-06438408001864 EUDAMED
B-06438408000263 EUDAMED
B-06438408001932 EUDAMED
B-06438408001550 EUDAMED
B-06438408001482 EUDAMED
B-06438408001567 EUDAMED
B-06438408001437 EUDAMED
B-06438408004506 EUDAMED
B-06438408000287 EUDAMED
B-06438408000249 EUDAMED
B-06438408002090 EUDAMED
B-06438408002960 EUDAMED
B-06438408000294 EUDAMED
B-06438408001642 EUDAMED
B-06438408000218 EUDAMED
B-06438408001987 EUDAMED
B-06438408001925 EUDAMED
Secondary DI
M224INS904010 EUDAMED
M224INS907610 EUDAMED
M224INS907910 EUDAMED
M224INS926510 EUDAMED
M224INS908210 EUDAMED
M224INS901110 EUDAMED
M224INS903010 EUDAMED
M224INS906010 EUDAMED
M224INS926410 EUDAMED
M224INS908410 EUDAMED
M224INS900910 EUDAMED
M224INS911410 EUDAMED
M224INS908110 EUDAMED
M224INS902710 EUDAMED
M224INS902910 EUDAMED
M224INS90879 EUDAMED
M224INS900410 EUDAMED
M224INS900110 EUDAMED
M224INS901410 EUDAMED
M224INS909610 EUDAMED
M224INS907810 EUDAMED
M224INS907110 EUDAMED
Direct Marketing DI
06438408000294 EUDAMED
06438408001642 EUDAMED
06438408001949 EUDAMED
06438408001482 EUDAMED
06438408000287 EUDAMED
06438408001987 EUDAMED
06438408001635 EUDAMED
06438408000249 EUDAMED
06438408002229 EUDAMED
06438408001550 EUDAMED
06438408000218 EUDAMED
06438408000263 EUDAMED
06438408001697 EUDAMED
06438408001970 EUDAMED
06438408001956 EUDAMED
06438408001567 EUDAMED
FDA Product Code
HTW FDA UDI
LXH FDA UDI
EMDN Code
L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
GMDN Term
Fluted surgical drill bit, reusable FDA UDI
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I EUDAMEDFDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
Finland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Inion CPS/OTPS instrumentation by Inion Oy — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Inion Oy
EUDAMED SRN
FI-MF-000000646

Sources (77)

  • EUDAMED 403cb0ca-8055-4e43-82c2-5296ec5c6070 61 fields · synced Sep 17, 2026
  • EUDAMED 3de41a6a-4001-4909-9040-7bafc7cfabb6 61 fields · synced May 16, 2026
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  • EUDAMED a324cb41-c1de-4296-ba14-5a970163da62 61 fields · synced May 17, 2026
  • EUDAMED ea65a8da-03cd-46e5-946a-54ed1be85ffc 61 fields · synced May 18, 2026
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  • EUDAMED 32f916eb-f288-419f-9fe9-04870f7f1639 61 fields · synced May 19, 2026
  • EUDAMED 495633fb-85a2-4f4a-b3a2-52763dbdd120 61 fields · synced May 19, 2026
  • FDA UDI 74404933-a773-45ae-acbf-37a6a6d0ea1c 34 fields · synced May 25, 2026
  • FDA UDI 710b2857-89bf-4bd8-b3cd-0070dc9e0758 34 fields · synced May 29, 2026
  • FDA UDI b3732dca-14f8-456d-9a28-3e503a1367f4 34 fields · synced May 30, 2026
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  • FDA UDI 386b4a0a-396c-492c-b244-c7e95e52314e 34 fields · synced May 30, 2026
  • EUDAMED ebe5cb1c-07c1-4128-a341-1e4be029dad9 61 fields · synced Jun 20, 2026
  • EUDAMED 3de1f9b0-36c0-4412-bd4e-5f341fa857fb 61 fields · synced Jul 9, 2026
  • EUDAMED 64a54bfe-61dd-4927-87ea-d3c56bae2bc9 61 fields · synced Jul 10, 2026
  • EUDAMED 615efd18-0b07-4285-b519-0d3e0bafc51e 61 fields · synced Jul 10, 2026
  • EUDAMED a2bd231a-2b89-4973-954d-8752d03d3f31 61 fields · synced Jul 11, 2026
  • EUDAMED 0442958c-7b59-4aea-8737-800254aad2e4 61 fields · synced Jul 11, 2026
  • EUDAMED 0c9108e8-b48e-41b2-afc4-ca3ba7f747c4 61 fields · synced Jul 12, 2026
  • EUDAMED d6816722-834c-4516-b03a-ac51e5ca362c 61 fields · synced Jul 12, 2026
  • EUDAMED de936319-8872-449a-b436-7e1ef952f0f3 61 fields · synced Jul 13, 2026
  • EUDAMED fbfb02d8-86e0-4621-a7f0-43e27a7a8078 61 fields · synced Jul 14, 2026
  • EUDAMED 8c563ab0-9feb-4463-ac53-3ed4c35fc81a 61 fields · synced Jul 14, 2026
  • EUDAMED 8075a4fc-c42d-442c-95ec-8288aedb96dc 61 fields · synced Jul 16, 2026
  • EUDAMED 47347103-8e98-4c92-b631-e2f7f7424367 61 fields · synced Jul 17, 2026
  • EUDAMED 6f6c9153-0ce4-4a39-8679-241b3ad01ccd 61 fields · synced Jul 21, 2026
  • EUDAMED e75a9a89-5926-42b8-9819-dee5271231ba 61 fields · synced Jul 23, 2026
  • EUDAMED 1b0931fc-9922-44c0-9002-dcb5c235ceab 61 fields · synced Jul 24, 2026
  • EUDAMED 8f3d1ebb-07db-4d17-9a3d-be94f39617c9 61 fields · synced Jul 28, 2026
  • EUDAMED 5e8d830f-ca3c-426c-a4ef-d32963525540 61 fields · synced Jul 30, 2026
  • EUDAMED e659cd8f-beee-483d-997f-97c43bec810a 61 fields · synced Jul 30, 2026
  • EUDAMED f1f0dac0-cc1d-435f-8c43-58967c7aba2a 61 fields · synced Aug 3, 2026
  • EUDAMED 023e11fa-46f2-4f33-ae3f-1bf8f26763dc 61 fields · synced Sep 17, 2026