510(k) K221697
- Device
- INJECTION PIN (KIP(02031-02061) (03031-03061))
- Applicant
- Slk Ortho, LLC
- 510(k) number
- K221697
- Product code
- NDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-03-03
- Date received
- 2022-06-10
- Regulation
- 888.3027
- Classification name
- Cement, Bone, Vertebroplasty
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Lawrence Kluge
- Address
- 5883 Rfd Long Grove IL US 60047 60047
FDA Registration Numbers
- 1423662
- 3005180920
- 3008125983
- 3021566676
- 2530808
- 9616662
- 1000461041
- 3004464325
- 3012536737
- 3027518990
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Source Documents
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