Acumed Pl-Ptack-S
by Acumed LLC
Acumed Pl-Ptack-S is a Class I device made by Acumed LLC, cleared under FDA 510(k) K233311 on 22 Apr 2024 and listed in FDA GUDID since 5 Jul 2024 (UDI-DI 10806378116704), 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 | Number10806378116704 | Date5 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233311 | Date22 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 10806378116704
- FDA 510(k) database K233311
Across registries
- FDA 510(k) K233311 decided 22 Apr 2024 Active
- FDA GUDID UDI-DI 10806378116704 listed 5 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K233311
- Listed FDA GUDID 10806378116704
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acumed
- Generic name
- Bone tack inserter, basic
- Model / reference
- PL-PTACK-S
- Primary DI / UDI-DI
- 10806378116704
- 510(k) Number
- FDA product code
- LXH
- GMDN term
- Bone tack inserter, basic
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
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