AOR X-RAY ALIGMENT PAD
FDA 510(k) clearance K837776 · decided 1983-08-18
Clearance details
- K-number
- K837776
- Device name
- AOR X-RAY ALIGMENT PAD
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-01-01
- Decision date
- 1983-08-18
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- IXJ
- Device class
- 1
- Regulation number
- 892.1910
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer
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 |
|---|---|---|
| MITAYA ALUMINUM INTERSPACED X-RAY GRID (K964025) | X-Ray Accessory Corp. | 1997-06-13 |
| FIBRE INTERSPACED X-RAY GRID (K963893) | Smit Rontgen | 1996-11-07 |
| RADIOGRAPHIC GRID (K962338) | Unidex Group, Inc. | 1996-07-03 |
| HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES (K954294) | Thermotrex Corp. | 1996-02-02 |
| SK S-RAY GRIDS (K945697) | Seibu Techno Coproration | 1995-01-31 |
| JPI X-RAY GRID (K945327) | Jpi America, Inc. | 1995-01-20 |
| GRIDGIL (K941626) | Gilardoni S.P.A. | 1994-05-13 |
| X-RAY GRID (RADIOLOGICAL GRID) (K940309) | J.P.I. Chicago Co. | 1994-04-22 |
| SOYEE ALUMINUM INTERSPACED X-RAY GRID (K926445) | X-Ray Accessories Mfg. Co. | 1993-04-07 |
| JPI ALUMINUM INTERSPACED X-RAY GRID (K926261) | Jpi, Inc. | 1993-03-18 |
| KODAK EKTASCAN SP CASSETTE (K925997) | Eastman Kodak Company | 1992-12-17 |
| RADIOGRAPHIC GRID (K901012) | Infab Corp. | 1990-03-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |