COMPRESSION HIP SCREW SYSTEM
FDA 510(k) clearance K850886 · decided 1985-04-19
Clearance details
- K-number
- K850886
- Device name
- COMPRESSION HIP SCREW SYSTEM
- Applicant
- Pfizer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-04
- Decision date
- 1985-04-19
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- KIT
- Device class
- 1
- Regulation number
- 864.2220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ny, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pfizer
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMNIO-GROW TM (K892938) | Inovar Biologicals, Inc. | 1989-05-22 |
| ENDOTHELIAL GROWTH MEDIUM (EGM) (K890701) | Clonetics Corp. | 1989-02-24 |
| MELANOCYTE GROWTH MEDIUM (MGM) (K890700) | Clonetics Corp. | 1989-02-24 |
| ABC, ABC-1X, ABC(TM) (K890482) | Cell Ent., Inc. | 1989-02-10 |
| ALPHACALF SERUM (K884654) | Hyclone Laboratories, Inc. | 1988-11-30 |
| HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (K884573) | Sigma Chemical Co. | 1988-11-22 |
| RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (K884572) | Sigma Chemical Co. | 1988-11-22 |
| DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (K884574) | Sigma Chemical Co. | 1988-11-22 |
| ALLOPREP SYSTEM (K883065) | Osteotech, Inc. | 1988-10-13 |
| FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (K884031) | Regency Biotech | 1988-10-06 |
| MEDIUM 199 W/EBSS (CATALOG NO. 200-2037) (K883951) | J R Scientific | 1988-09-30 |
| CHANG MEDIUM (ADDITIONAL INDICATIONS) (K883682) | Hana Biologics, Inc. | 1988-09-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw sys recall (Z-1865-2008) | Stryker Howmedica Osteonics Corp. | 2008-09-16 |
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 |