Arthrex ABS-2012-01
Arthrex ABS-2012-01 is a Class II device made by Isotis Orthobiologics, Inc, cleared under FDA 510(k) K040419 on 25 Mar 2005 and listed in FDA GUDID since 17 Nov 2017 (UDI-DI 10889981153618), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889981153618 | Date17 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040419 | Date25 Mar 2005 | StatusActive |
Official records
- AccessGUDID record 10889981153618
- FDA 510(k) database K040419
Across registries
- FDA 510(k) K040419 decided 25 Mar 2005 Active
- FDA GUDID UDI-DI 10889981153618 listed 17 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K040419
- Listed FDA GUDID 10889981153618
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arthrex
- Generic name
- Human-derived demineralized bone matrix implant
- Model / Ref / Catalog
- ABS-2012-01
- Primary DI / UDI-DI
- 10889981153618
- 510(k) Number
- FDA product code
- MQV
- GMDN term
- Human-derived demineralized bone matrix implant
- Device class
- Class II
- Regulation number
- 888.3045
- GUDID distribution status
- In Commercial Distribution
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