ACL DRILL GUIDE SYSTEM
FDA 510(k) clearance K892655 · decided 1989-09-28
Clearance details
- K-number
- K892655
- Device name
- ACL DRILL GUIDE SYSTEM
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-04-13
- Decision date
- 1989-09-28
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- LXI
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNVASIVE CERAMIC SUTTING BLOCK (K930573) | Synvasive Technology, Inc. | 1994-04-07 |
| VILLAN (VIDEO LIFT LINK ANALYSIS) (K910712) | Physio Systems, Inc. | 1991-05-21 |
| PERSONAL ALERT ASSIST DEVICE (K890445) | Silent Call Corp. | 1989-05-19 |
| BOW & ARROW DRILL GUIDE (K882407) | Instrument Makar, Inc. | 1988-09-06 |
| PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (K881378) | Pfizer, Inc. | 1988-06-17 |
| DYONICS DRILL GUIDE/ISOMETER SYSTEM (K880739) | Dyonics, Inc. | 1988-03-21 |
| TENSION-ISOMETER (K854254) | Medmetric Corp. | 1985-11-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |