Product code LXI
- Device name
- Guide, Drill, Ligament
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4820
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | Synvasive Technology, Inc. | 1994-04-07 |
| K910712 | VILLAN (VIDEO LIFT LINK ANALYSIS) | Physio Systems, Inc. | 1991-05-21 |
| K892655 | ACL DRILL GUIDE SYSTEM | Baxter Healthcare Corp | 1989-09-28 |
| K890445 | PERSONAL ALERT ASSIST DEVICE | Silent Call Corp. | 1989-05-19 |
| K882407 | BOW & ARROW DRILL GUIDE | Instrument Makar, Inc. | 1988-09-06 |
| K881378 | PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE | Pfizer, Inc. | 1988-06-17 |
| K880739 | DYONICS DRILL GUIDE/ISOMETER SYSTEM | Dyonics, Inc. | 1988-03-21 |
| K854254 | TENSION-ISOMETER | Medmetric Corp. | 1985-11-15 |
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|---|---|---|---|
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| 00888867500907 | Arthrex® | ARTHREX, INC. | 2026-03-13 |
| 00888867500938 | Arthrex® | ARTHREX, INC. | 2026-03-13 |
| 00888867500976 | Arthrex® | ARTHREX, INC. | 2026-03-13 |
| 00888867500990 | Arthrex® | ARTHREX, INC. | 2026-03-13 |
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| 00840124520257 | PolyLock Midfoot | FUSION ORTHOPEDICS, LLC | 2025-05-16 |
| 00840124520233 | PolyLock Midfoot | FUSION ORTHOPEDICS, LLC | 2025-05-16 |
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| 05060433600807 | LSSS | Lockdown Medical Ltd | 2020-07-24 |
| 00889024570221 | ZNN | Zimmer, Inc. | 2019-02-18 |