PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
FDA 510(k) clearance K881378 · decided 1988-06-17
Clearance details
- K-number
- K881378
- Device name
- PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-04-01
- Decision date
- 1988-06-17
- Days to decision
- 77 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
- Groton, CT, 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 |
| ACL DRILL GUIDE SYSTEM (K892655) | Baxter Healthcare Corp | 1989-09-28 |
| PERSONAL ALERT ASSIST DEVICE (K890445) | Silent Call Corp. | 1989-05-19 |
| BOW & ARROW DRILL GUIDE (K882407) | Instrument Makar, Inc. | 1988-09-06 |
| 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 |
|---|---|---|
| GELFOAM (absorbable gelatin gel, powder from abs. gel, sponge USP), GELFOAM (compressed absorbable gelatin sponge, USP), (N18286/S041) | Pfizer, Inc. | 2023-05-16 |
| (Gelfoam (absorbable gelatin) Sterile Sponge) (N18286/S040) | Pfizer, Inc. | 2022-06-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S038) | Pfizer, Inc. | 2021-05-07 |
| Gelfoam Sterile Sponge (N18286/S037) | Pfizer, Inc. | 2021-02-24 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S035) | Pfizer, Inc. | 2020-03-19 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |