510(k) K102487
- Device
- NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
- Applicant
- EXACTECH, INC.
- 510(k) number
- K102487
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-11-08
- Date received
- 2010-08-30
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VLADISLAVA ZAITSEVA
- Address
- 2320 NW 66th Ct. Gainesville FL US 32653 32653
FDA Registration Numbers#
- 3014272734
- 3010047454
- 3020967480
- 3013450937
- 1833506
- 1836357
- 1000200989
- 1226544
- 3027484613
- 1038671
- 3009871135
- 3004188066
- 3013302242
- 1828464
- 1220477
- 3007391088
- 3015167917
- 3012916784
- 3000264985
- 3012119238
- 3010163695
- 3015516266
- 3007353762
- 3002807408
- 3009882462
- 3006801265
- 3010386387
- 3004153240
- 3007120646
- 3004513872
- 3011274144
- 3015259876
- 3003639920
- 9616680
- 2249697
- 3009475821
- 3008668801
- 3000196378
- 3013194153
- 2648920
- 2242737
- 1818910
- 1835572
- 3010288357
- 3002807314
- 3026776
- 3005180920
- 9610612
- 3010039400
- 3002808022
- 1218882
- 3010375065
- 3009241418
- 3012439458
- 3008395353
- 3013055499
- 2246552
- 3016438694
- 3018052045
- 1531174
- 1529009
- 3007334927
- 1226188
- 1018470
- 3005751028
- 3010206549
- 1000294921
- 3008281151
- 3011461101
- 3030338875
- 3012523063
- 3008793310
- 3002807112
- 3020282716
- 3004153896
- 3005718816
- 3014170143
- 3004371426
- 3003791208
- 9613350
Source Documents#
Other 510(k) Records For Product Code LZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2026-10-01 |
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026-09-17 |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026-09-02 |
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 |
| K260182 | Avenir® Müller Stem; Avenir Complete™ Hip System | Zimmer, Inc. | 2026-04-27 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 |
Legacy Summary#
summary
FDA Review#
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