510(k) K964953
- Device
- IN-TAC BONE ANCHOR SYSTEM
- Applicant
- INFLUENCE, INC.
- 510(k) number
- K964953
- Product code
- HXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-13
- Date received
- 1996-12-05
- Regulation
- 888.4540
- Classification name
- Staple Driver
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK D KRAMER
- Address
- 12307 Winesap Ter. North Potomac MD US 20878 20878
FDA Registration Numbers#
- 3009423112
- 3002808227
- 3007366790
- 3016851379
- 1220246
- 3002579136
- 3008285983
- 9710629
- 3013946322
- 3038503932
- 8044102
- 3014004349
- 8040278
- 3011230048
- 3005579585
- 3015231789
- 3027242374
- 3013846070
- 3013156185
- 3023852420
- 1020279
- 9615765
- 9613910
- 9611283
- 9680518
- 3009417901
- 3003755939
- 3020704423
- 1054811
- 3014554088
- 3013011598
- 3019269298
- 3010400367
- 3014262693
- 3006017180
- 3027339877
- 3015974593
- 3012883081
- 3031240334
- 3010331645
- 3010303097
- 3005273623
- 3008744062
- 3002808270
- 3010470577
- 3016727307
Source Documents#
Other 510(k) Records For Product Code HXJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962372 | UROTAC BONE ANCHOR INSERTER | Influence, Inc. | 1996-08-19 |
| K930205 | ELECTRIC WIRE DRIVER, MODEL 2640E | Micro Surgical Instruments Corp. | 1993-08-02 |
| K834515 | FIXATION STAPLE KIT - DLIDE HAMMER | Stryker Corp. | 1984-04-23 |
| K830255 | OSTEOTOMY BONE STAPLE | Techmedica, Inc. | 1983-03-09 |
| K830456 | STAPLE INSERTER-EXTRACTOR FOR ARTHROS | Instrument Makar, Inc. | 1983-03-09 |
Legacy Summary#
summary
FDA Review#
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