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ActivaScrew™ Interference TCP
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref B-DI-0510Ref B-DI-0520Ref B-DI-1028Ref B-DI-0933Ref B-DI-0410Ref B-DI-0626Ref B-DI-1024Ref B-DI-0724Ref B-DI-0828Ref B-AI-1128Ref B-AI-0615Ref B-DI-1033Ref B-DI-0920Ref B-DI-0830Ref B-AI-1024Ref B-AI-0830Ref B-AI-0520Ref B-AI-0726Ref B-DI-1030Ref B-DI-0515Ref B-AI-0820Ref B-AI-0515Ref B-DI-0620Ref B-AI-0833Ref B-DI-1130Ref B-DI-0415Ref B-DI-0615Ref B-DI-0726Ref B-AI-1033Ref B-AI-0933
Identity
- Trade Name
- ActivaScrew™ Interference TCP EUDAMEDActivaScrew™ Interference EUDAMED
- Device Name
- ActivaScrew™ Interference TCP 5 x 10 mm EUDAMEDActivaScrew™ Interference TCP 5 x 20 mm EUDAMEDActivaScrew™ Interference TCP 10 x 28 mm EUDAMEDActivaScrew™ Interference TCP 9 x 33 mm EUDAMEDActivaScrew™ Interference TCP 4 x 10 mm EUDAMEDActivaScrew™ Interference TCP 6 x 26 mm EUDAMEDActivaScrew™ Interference TCP 10 x 24 mm EUDAMEDActivaScrew™ Interference TCP 7 x 24 mm EUDAMEDActivaScrew™ Interference TCP 8 x 28 mm EUDAMEDActivaScrew™ Interference 11 x 28 mm EUDAMEDActivaScrew™ Interference 6 x 15 mm EUDAMEDActivaScrew™ Interference TCP 10 x 33 mm EUDAMEDActivaScrew™ Interference TCP 9 x 20 mm EUDAMEDActivaScrew™ Interference TCP 8 x 30 mm EUDAMEDActivaScrew™ Interference 10 x 24 mm EUDAMEDActivaScrew™ Interference 8 x 30 mm EUDAMEDActivaScrew™ Interference 5 x 20 mm EUDAMEDActivaScrew™ Interference 7 x 26 mm EUDAMEDActivaScrew™ Interference TCP 10 x 30 mm EUDAMEDActivaScrew™ Interference TCP 5 x 15 mm EUDAMEDActivaScrew™ Interference 8 x 20 mm EUDAMEDActivaScrew™ Interference 5 x 15 mm EUDAMEDActivaScrew™ Interference TCP 6 x 20 mm EUDAMEDActivaScrew™ Interference 8 x 33 mm EUDAMEDActivaScrew™ Interference TCP 11 x 30 mm EUDAMEDActivaScrew™ Interference TCP 4 x 15 mm EUDAMEDActivaScrew™ Interference TCP 6 x 15 mm EUDAMEDActivaScrew™ Interference TCP 7 x 26 mm EUDAMEDActivaScrew™ Interference 10 x 33 mm EUDAMEDActivaScrew™ Interference 9 x 33 mm EUDAMED
- Model / Reference
- B-DI-0510 EUDAMEDB-DI-0520 EUDAMEDB-DI-1028 EUDAMEDB-DI-0933 EUDAMEDB-DI-0410 EUDAMEDB-DI-0626 EUDAMEDB-DI-1024 EUDAMEDB-DI-0724 EUDAMEDB-DI-0828 EUDAMEDB-AI-1128 EUDAMEDB-AI-0615 EUDAMEDB-DI-1033 EUDAMEDB-DI-0920 EUDAMEDB-DI-0830 EUDAMEDB-AI-1024 EUDAMEDB-AI-0830 EUDAMEDB-AI-0520 EUDAMEDB-AI-0726 EUDAMEDB-DI-1030 EUDAMEDB-DI-0515 EUDAMEDB-AI-0820 EUDAMEDB-AI-0515 EUDAMEDB-DI-0620 EUDAMEDB-AI-0833 EUDAMEDB-DI-1130 EUDAMEDB-DI-0415 EUDAMEDB-DI-0615 EUDAMEDB-DI-0726 EUDAMEDB-AI-1033 EUDAMEDB-AI-0933 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394011953 EUDAMED06438394011670 EUDAMED06438394011779 EUDAMED06438394011885 EUDAMED06438394011939 EUDAMED06438394011687 EUDAMED06438394011762 EUDAMED06438394011700 EUDAMED06438394011724 EUDAMED06438394010925 EUDAMED06438394007406 EUDAMED06438394011908 EUDAMED06438394011748 EUDAMED06438394011847 EUDAMED06438394007550 EUDAMED06438394007499 EUDAMED06438394007390 EUDAMED06438394007451 EUDAMED06438394011892 EUDAMED06438394011960 EUDAMED06438394009127 EUDAMED06438394007383 EUDAMED06438394011793 EUDAMED06438394007505 EUDAMED06438394011915 EUDAMED06438394011946 EUDAMED06438394011977 EUDAMED06438394011816 EUDAMED06438394007581 EUDAMED06438394007543 EUDAMED
- Basic UDI-DI
- B-06438394011953 EUDAMEDB-06438394011670 EUDAMEDB-06438394011779 EUDAMEDB-06438394011885 EUDAMEDB-06438394011939 EUDAMEDB-06438394011687 EUDAMEDB-06438394011762 EUDAMEDB-06438394011700 EUDAMEDB-06438394011724 EUDAMEDB-06438394010925 EUDAMEDB-06438394007406 EUDAMEDB-06438394011908 EUDAMEDB-06438394011748 EUDAMEDB-06438394011847 EUDAMEDB-06438394007550 EUDAMEDB-06438394007499 EUDAMEDB-06438394007390 EUDAMEDB-06438394007451 EUDAMEDB-06438394011892 EUDAMEDB-06438394011960 EUDAMEDB-06438394009127 EUDAMEDB-06438394007383 EUDAMEDB-06438394011793 EUDAMEDB-06438394007505 EUDAMEDB-06438394011915 EUDAMEDB-06438394011946 EUDAMEDB-06438394011977 EUDAMEDB-06438394011816 EUDAMEDB-06438394007581 EUDAMEDB-06438394007543 EUDAMED
- EMDN Code
- P09120605 INTERFERENCE SCREWS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tendon/ligament bone anchor, non-bioabsorbable
ActivaScrew™ Interference TCP by Bioretec Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
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- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130716 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06438394011953 | Class III | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (31)
- EUDAMED 3d08efa1-196d-4f26-9ee5-5b3f23a220c9 61 fields · synced Sep 17, 2026
- EUDAMED e46df3b0-9961-4acd-b7a0-79be28364246 61 fields · synced May 16, 2026
- EUDAMED d18e0237-4b03-4c9d-933d-9225ef4f92dc 61 fields · synced May 16, 2026
- EUDAMED 5f58ceac-967a-4a7c-8111-17c2250a373c 61 fields · synced May 16, 2026
- EUDAMED d44318ea-4708-4941-a094-062f0a019b16 61 fields · synced May 16, 2026
- EUDAMED ad99625d-297f-406a-b41f-06a38b499f3c 61 fields · synced May 16, 2026
- EUDAMED c817929f-d32c-4008-9584-fd41b1090aa9 61 fields · synced May 16, 2026
- EUDAMED 5979e04e-c741-4571-bfb4-517453b31fcc 61 fields · synced May 16, 2026
- EUDAMED e13c6082-22ce-4917-8d57-4a88c7a556d5 61 fields · synced May 16, 2026
- EUDAMED 0dfc0f92-826a-49ae-b578-d13ec560e7f7 61 fields · synced May 16, 2026
- EUDAMED bd558717-1196-4ce0-aadd-83da2acba1cb 61 fields · synced May 17, 2026
- EUDAMED 4c5ad3e3-5038-42c3-8284-9dd579e15485 61 fields · synced May 17, 2026
- EUDAMED 8c57f0c3-5576-446b-b6e3-bef680416719 61 fields · synced May 17, 2026
- EUDAMED 50fba44b-3f3d-4108-ba25-918a0824f2bf 61 fields · synced May 17, 2026
- EUDAMED 6a93d752-d9e1-4f4f-a89a-0f4f33a74dea 61 fields · synced May 17, 2026
- EUDAMED d3e3f221-b80a-455a-bb83-53194c4675c5 61 fields · synced May 17, 2026
- EUDAMED fd7b0c83-25fb-4ed0-b7ba-9a4cdb189758 61 fields · synced May 18, 2026
- EUDAMED 9ae59ec9-c66c-4ea1-9013-d6d1adc1a489 61 fields · synced May 18, 2026
- EUDAMED 25f570cf-a6fe-4226-8d4c-f821425da5cc 61 fields · synced May 18, 2026
- EUDAMED d9896c8d-ae58-4394-b835-533aaf877ed2 61 fields · synced May 18, 2026
- EUDAMED c05b496a-c3ba-46d7-8936-de13a0798b08 61 fields · synced May 18, 2026
- EUDAMED 05e09ee3-d9b1-422e-94a8-15dbe49c003b 61 fields · synced May 18, 2026
- EUDAMED ec3fa64b-593e-4e62-8d1d-90650893c7ce 61 fields · synced May 18, 2026
- EUDAMED b85d87aa-8cb9-4d77-89b8-dbc630cec101 61 fields · synced May 18, 2026
- EUDAMED 47459e34-7c33-461d-b751-ba3f3557e1fd 61 fields · synced May 18, 2026
- EUDAMED fb8fe693-ba82-412d-8781-dd3b04b0ea4a 61 fields · synced May 18, 2026
- EUDAMED d60633df-2ffe-4395-99ea-c90829f1fa50 61 fields · synced May 18, 2026
- EUDAMED cf845236-9ecc-49ec-997e-708cc99e0d32 61 fields · synced May 19, 2026
- EUDAMED bcf1cc8e-f720-4898-8790-cef175af91bd 61 fields · synced May 19, 2026
- EUDAMED 8390f63f-3655-46da-a8ea-c8e7e9540c98 61 fields · synced May 19, 2026
- FDA 510(k) K130716 1 fields · synced May 18, 2026