The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Hall Modular Acetabular Reamer System.
| Device ID | K960852 |
| 510k Number | K960852 |
| Device Name: | HALL MODULAR ACETABULAR REAMER SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman,ph.d. |
| Correspondent | Carol A Weideman,ph.d. LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-01 |
| Decision Date | 1996-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10845854022634 | K960852 | 000 |
| 10845854022467 | K960852 | 000 |
| 10845854022450 | K960852 | 000 |
| 10845854022443 | K960852 | 000 |
| 10845854022436 | K960852 | 000 |
| 10845854022429 | K960852 | 000 |
| 10845854022412 | K960852 | 000 |
| 10845854022405 | K960852 | 000 |
| 10845854022399 | K960852 | 000 |
| 10845854022382 | K960852 | 000 |
| 10845854022375 | K960852 | 000 |
| 10845854022368 | K960852 | 000 |
| 10845854022351 | K960852 | 000 |
| 10845854022344 | K960852 | 000 |
| 10845854022474 | K960852 | 000 |
| 10845854022481 | K960852 | 000 |
| 10845854022498 | K960852 | 000 |
| 10845854022627 | K960852 | 000 |
| 10845854022610 | K960852 | 000 |
| 10845854022603 | K960852 | 000 |
| 10845854022597 | K960852 | 000 |
| 10845854022580 | K960852 | 000 |
| 10845854022573 | K960852 | 000 |
| 10845854022566 | K960852 | 000 |
| 10845854022559 | K960852 | 000 |
| 10845854022542 | K960852 | 000 |
| 10845854022535 | K960852 | 000 |
| 10845854022528 | K960852 | 000 |
| 10845854022511 | K960852 | 000 |
| 10845854022504 | K960852 | 000 |
| 10845854022337 | K960852 | 000 |