The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Corb Tm Counterrotating Biopsy Needle.
| Device ID | K811005 |
| 510k Number | K811005 |
| Device Name: | CORB TM COUNTERROTATING BIOPSY NEEDLE |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | ZIMMER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-14 |
| Decision Date | 1981-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024066267 | K811005 | 000 |
| 00889024066151 | K811005 | 000 |
| 00889024066168 | K811005 | 000 |
| 00889024066175 | K811005 | 000 |
| 00889024066182 | K811005 | 000 |
| 00889024066199 | K811005 | 000 |
| 00889024066205 | K811005 | 000 |
| 00889024066212 | K811005 | 000 |
| 00889024066229 | K811005 | 000 |
| 00889024066236 | K811005 | 000 |
| 00889024066243 | K811005 | 000 |
| 00889024066250 | K811005 | 000 |
| 00889024066144 | K811005 | 000 |