Panels › Orthopedic › Product code JEC · Class 2
Component, Traction, Invasive
Regulation 888.3040
0510(k)s in 12 months (85 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in JEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Howmedica Corp. | 13 | 0 |
| Ace Orthopedic Manufacturing Co. | 5 | 0 |
| Hand Biomechanics Lab, Inc. | 4 | 1 |
| Synthes (Usa) | 4 | 0 |
| Acu Med, Inc. | 3 | 0 |
| Anjon Holdings, LLC | 2 | 1 |
| Jerome Medical | 3 | 0 |
| Ace Medical Co. | 2 | 0 |
| Autogenesis, Inc. | 2 | 0 |
| Buckman Co., Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 1990 | K894098 | SYNTHES EXTERNAL FIXATION BONE CLIP Synthes (Usa) | JEC |
| Jan 11, 1990 | K894982 | ACE WIRE TENSION CLAMP Buckman Co., Inc. | JEC |
| Aug 11, 1989 | K892638 | TRACER DYNAMIC AXIAL FIXATION Tracer Medical | JEC |
| Feb 10, 1989 | K884798 | AME PINSITE SHIELD(TM) American Medical Electronics, Inc. | JEC |
| Dec 29, 1988 | K884242 | MODIFIED CHICK AMBULATORY HALO Chick Medical Products | JEC |
| Sep 30, 1988 | K882877 | JMS CERVICAL TRACTION DEVICE/HALO DEVICE Jerome Medical | JEC |
| Jul 28, 1988 | K881896 | KIRSCHNER SUPER-FIXATION SYSTEM Kirschner Medical Corp. | JEC |
| Jun 3, 1988 | K881673 | LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER Lima-Lto, Inc. | JEC |
| Feb 18, 1988 | K880282 | LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER Lima-Lto, Inc. | JEC |
| Jul 10, 1987 | K872538 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS Vitaphore Corp. | JEC |
| Aug 9, 1985 | K852397 | EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) Howmedica Corp. | JEC |
| Feb 13, 1985 | K842493 | AGEE EXTERNAL FIXATOR The Hand Biomechanics Research Laboratory | JEC |
| Sep 11, 1984 | K842343 | SABA-COOMBS MINI EXTERNAL FIXATOR Zimmer, Inc. | JEC |
| May 16, 1984 | K841334 | RICHARDS FIXATOR SYSTEM Richards Medical Co., Inc. | JEC |
| Apr 25, 1984 | K840856 | MODULAR CONSTRUCT FRAME EXTERNAL FIXA Precision Medical Devices, Inc. | JEC |
| Oct 20, 1983 | K833114 | OXFORD MARK 2 EXTERNAL FIXATOR Johnson & Johnson Professionals, Inc. | JEC |
| Jun 8, 1983 | K831576 | ORTHOFIX Electro-Biology, Inc. | JEC |
| Feb 2, 1983 | K830154 | COLLES FRACTURE FRAME Richard'S Medical Equip., Inc. | JEC |
| Oct 6, 1982 | K822780 | CERVICAL BRACE Jerome Medical | JEC |
| Jan 9, 1981 | K803166 | DOUBLE BALL JOINT Howmedica Corp. | JEC |
| Dec 10, 1980 | K802814 | ORTHOFIX AXIALEXTERNAL FIXATION SYS. Cintor Orthopaedic Div. | JEC |
| Nov 19, 1980 | K802776 | HOFFMAN LEG LENGTHENING DEVICE Howmedica Corp. | JEC |
| Nov 19, 1980 | K802723 | EXTENDED BALLJOINT GRIP Howmedica Corp. | JEC |
| Nov 19, 1980 | K802722 | EXTERNAL FIXATION SYSTEM Howmedica Corp. | JEC |
| Feb 11, 1980 | K800184 | OXFORD EXTERNAL FIXATION SYSTEM Downs Surgical , Ltd. | JEC |
| Dec 19, 1979 | K792561 | MINI-H-FIXATION Geny Medical, Inc. | JEC |
| Aug 16, 1979 | K791466 | ACE EXTERNAL BONE CLAMP PART #S11 Ace Orthopedic Manufacturing Co. | JEC |
| Feb 13, 1979 | K790262 | UNIVERSAL EXTERNAL FIXATION ASSEMBLY Zimmer, Inc. | JEC |
| Nov 8, 1978 | K781841 | BAR, DISTRACTION Ace Orthopedic Manufacturing Co. | JEC |
| Nov 8, 1978 | K781840 | EXTERNAL ARTICULATION Ace Orthopedic Manufacturing Co. | JEC |
| Nov 8, 1978 | K781839 | BONE CLAMP, ACE EXTERNAL Ace Orthopedic Manufacturing Co. | JEC |
| Nov 3, 1978 | K781793 | FRAME, UNIVERSAL DAY B.G. Orthopedic Corp. | JEC |
| Mar 30, 1977 | K770066 | TIBIAL COMPRESSION FRAM FOR FRACTURES Richard F. Kronner, M.D. | JEC |
| Mar 14, 1977 | K770388 | FRACTURE REDUCTION SYS., MODEL OR 1001 Sisan Assoc. | JEC |
| Dec 17, 1976 | K761088 | DEPUY MODIFIED SKELETAL TRACTION PIN Depuy, Inc. | JEC |
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